Attachment 1 - SOW - PATS 04.04.2024.pdf

US Department of Agriculture (USDA)

Statement of Work

Portable Audiometric Testing-Device and Services (PATS)

Dated: 20 March 2024

Solicitation Number: 123A94-24-Q-0018

Food Safety and Inspection Service (FSIS)

Hearing Conservation Program (HCP)

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A. Background

The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) protects consumers by ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled.

The USDA FSIS Office of Field Operations (OFO) Inspector in Charge (IIC) supervises Consumer Safety Inspectors (CSIs) at various processing and slaughter plants. CSIs ensure that regulated establishments produce a safe product by executing appropriate inspection methods, documenting noncompliance with regulatory requirements, and initiating enforcement actions where warranted. FSIS plant personnel are required to work in close proximity to tools, equipment, and machinery which increase exposure to potentially damaging noise levels and may impact employee and environmental safety. Due to increased variability of working conditions and noise exposure levels within these processing and slaughter plants, USDA has implemented the Occupational Safety and Health Administration’s (OSHA) general requirement to establish a Hearing Conservation Program (HCP).

HCPs seek to prevent initial occupational hearing loss by equipping personnel with the knowledge and hearing protection devices necessary to safeguard themselves.1 In accordance with OSHA 29 CFR 1910.95, the USDA HCP administers to personnel whose work environments generate noise exposure levels greater than or equal to an 8-hour time-weighted average (TWA) sound level of 85 decibels. All FSIS In-Plant Personnel (IPP) have the option to enroll in the HCP given their ubiquitous exposure to hazardous noise levels unless noise dosimetry monitoring confirms otherwise. FSIS plant personnel shall follow the HCP program elements as stated in OSHA’s Noise Exposure Standard, 29 CFR 1910.95.

Participants have the option to undergo one (1) annual audiometric exam conducted by an OSHA-certified technician or physician to evaluate their exposure to noise levels in excess of the aforementioned threshold. FSIS currently conducts these examinations on an ad hoc basis through verified vendors across USDA’s multiple Districts.

B. Objective/Scope

The objective of this requirement is to procure “Portable Audiometric Testing Devices” for use throughout USDA’s ten (10) Districts. The contractor shall ensure provision of annual audiometric examination services for an estimated 7,400 FSIS HCP participants. The contractor shall ensure audiometric examination services are conducted for all participants electing to receive testing. The contractor shall ensure efficient management of the HCP, provide analyses of employee test results, and implement a HIPPA-compliant repository or database for the collecting and storing of all test data. The data repository will allow Occupational Safety and Health (OSH) professionals and other designated individuals to evaluate most recent audiograms against baseline audiograms to determine whether a Standard Threshold Shift (STS) occurred. All STS retests must be confirmed within 30-day period as required by OSHA’s Noise Exposure Standard in coordination with the district’s supervisor who is assigned the area of responsibility that employee works. This method of data-tracking and record-keeping will facilitate the need for any follow-up audiograms and/or retesting. This repository will remain the property of FSIS upon completion of the contract.

This contract seeks to ensure the following:

1. FSIS personnel working in remote locations are provided the most cost-effective options for annual audiometric examinations.

1 Occupational Noise Exposure - Hearing Conservation Program | Occupational Safety and Health Administration (osha.gov)

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2. Services for audiometric examinations are extended throughout all 10 USDA Districts to include the more remote and rural slaughter and processing plants.

3. Follow-up retesting to confirm an STS if the initial audiogram points to a potential STS.

Additionally, the contractor audiologist shall provide specific employee guidance and counseling as needed and make recommendations for additional medical exam if warranted.

4. A central database or repository which captures existing and historical audiometric data.

C. Period of Performance (POP):

The period of performance for the main services is anticipated to be July 1, 2024 to June 30, 2025, with four (4) twelve (12) month option periods available. The phase in CLIN shall take place after contract award which is anticipated to at the end of May 2024. The Phase-In CLIN will have a one-month Period of Performance to be contract award through 30 June 2024.

1. Phase In Period: The below lead times can happen simultaneously. All below subparagraphs shall take no more than 4 weeks for full period of performance to start by 1 July 2024

(a) Import of historical data

a. Contractor will be provided with CSV file containing all employees baseline tests. Contract needs to import historical data for each employee into their secure database. This exact time frame will be provided at time of award. We anticipate this process taking a week at most.

(b) Shipment and delivery of devices to centralized/headquarter building for each district shall occur within 2 weeks after contract award.

(c) Deployment Support and system setup shall occur within 1 week after delivery of devices. This will ensure a fully system setup has occurred.

(d) Services Training & Onboarding shall occur within 1 week of devices being delivered. Training can be done with a group training methodology and can be delivered electronically (webinar).

(e) FSIS needs the capability of having a designated kickoff test that occurs 1 week before the planned test dates to ensure equipment and services are operating at ideal levels and to verify that the room meets the background noise requirements for testing.

2. The above milestones shall begin before any portable audiometric testing services can be accomplished. This shall be captured in the phase in period. Once complete, the Period of Performance for the services will be began. The total duration of the timelines from (a) – (e ) shall take no more than 8 weeks total.

D. Contractor Requirements

1. Phase-In Process

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(a) Training:

(i) The contractor shall provide phase-in training to Safey Specialists and Front-Line Supervisors (FLS) to ensure personnel are knowledgeable of equipment operation, audiology testing process, record keeping as well as the secure transfer of data in accordance with federal laws, regulations and requirements.

2. The contractor shall input into the contractor’s portal/database baseline scores for all newly hired employees onboarding after the date of award throughout the duration of the contract. The COR will provide to the contractor monthly, an accessions report and individual baseline audiograms in PDF format for each new hire. The contractor shall upload the files within 60 calendar days of COR notification upload. The contractor shall provide written notification to the COR that the employee’s data has been entered into the contractor’s portal/database.

3. The contractor shall conduct quality control actions in conjunction with the COR to ensure accuracy of employee information, audiogram results and security of medical records. When an employee’s baseline audiogram is missing, the new annual audiogram that they are taking as part of this effort will serve as a baseline going forward.

4. The contractor shall provide logistical support in the tracking of devices/equipment in conjunction with the government’s appointed property manager. Annual calibration of devices will be coordinated with the COR and Program Manager. The contractor will notify the government of the calibrations schedule. 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.

5. The contractor shall ensure audiometric testing is made available to all FSIS employees participating in the HCP across USDA’s existing U.S. circuits. The districts are identified below, including the total number Establishments. Data specific to each State and/or Establishment can be found at https://www.fsis.usda.gov/inspection/establishments/meat-poultry-and-egg-product-inspection-directory.

(a) District 80– Delaware, District of Columbia, Maryland, New Jersey, North Carolina, Virginia, West Virginia Total number of employees: 859

(b) District 90 – Alabama, Kentucky, Mississippi, Tennessee, Virginia Total number of employees: 866

(c) District 25 – Illinois, Iowa, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin Total number of employees: 814

(d) District 85 – Florida, Georgia, Puerto Rico, South Carolina, and the U.S. Virgin Islands Total number of employees: 826

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(e) District 15 – Alaska, American Samoa, Arizona, California, Colorado, Guam, Hawaii, Idaho, Montana, Nebraska, New Mexico, Northern Mariana Islands, Oregon, South Dakota, Utah, Washington, Wyoming Total number of employees: 777

(f) District 35 – Arkansas, Kansas, Missouri, Oklahoma Total number of employees: 766

(g) District 40 – Arizona, Arkansas, Louisiana, New Mexico, Oklahoma, and Texas Total number of employees: 795

(h) District 50 – Illinois, Indiana, Michigan, Ohio and Wisconsin Total number of employees: 588

(i) District 05 – Arizona, California, and Nevada Total number of employees: 545

(j) District 60 - Connecticut, Maine, Massachusetts, New Hampshire, New York, Pennsylvania, Rhode Island, Vermont Total number of employees: 559

E. Contractor Tasks/Deliverables:

1. Audiometric Tests

(a) Audiometric tests must include the following:

(i) Individual testing of right and left ears via air-conduction, pure-tone, hearing threshold measures at no less than 500, 1000, 2000, 4000, and 6000 hertz (Hz); the 8000 Hz threshold will be tested whenever the etiology of a hearing loss may be in question.

(ii) Testing must be conducted with audiometers which meet the specifications of and are maintained per the American National Standard Specifications for Audiometers, ANSI S3.6.

(iii) Testing room ambient noise levels must conform to the American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms, ANSI S3.1.

(b) All audiograms obtained must meet the requirements of OSHA 29 CFR 1910.95, Occupational Noise Exposure, Appendix C: Audiometric Measuring Instruments

(c) Use of microprocessor-based or self-recording audiometers does not waive the qualification requirements for the tester. The professional notation must be recorded on each worker’s audiogram.

F. Technical Requirements:

All of the below are required to comply with the following standards from Occupational Health and Safety Administration (OSHA) ‘29 CFR part 1910 Occupational Safety and Health Standards, Subpart G, Attachment 1 ‐ Page 5 of 11

Occupational Health and Environmental Control, standard 1910.95 Occupational Noise Exposure’ for hearing testing and hearing conservation programs (to include all calibration requirements).

1. Designed and optimized for use outside sound booth.

2. Portable is defined as a device (tablet-based system) light weight - not to exceed 5 pounds and small enough to be easily carried or moved by a single individual, practical and ultra compact in design. Shall also be available to transport easily to various test sites by one individual user.

3. Acoustic Headphones with foam insulation shall be used and included. Headphones shall have annual calibration at no additional cost to FSIS and meet current ANSI S3.6 & CSA Z107.6-16 standards & IEC 60645-1 & 60645-3. A DD450 Headphone has been found to be acceptable. That headphone standard or better (if available) shall be used. If a microphone is needed, a class 2 Microphone is required at no additional cost.

4. Provides option between fully automated/self-test or assisted test modes for employees who require assistance. Software must allow for user to retest at pure tone frequency if background noise levels are exceeded or as other anomalies occur.

5. Software must ensure employees verify the correctness of their personal information and to contact Human Resources if corrections are required.

6. Software must incorporate agency Privacy Act Statement requirements and shall include a paragraph notifying employees of their rights and responsibilities.

7. Portable Audiometers / No Tele-Hybrid Solutions (no Technicians are allowed onsite at FSIS establishments to proctor exams).

8. Portable Audiometer support administering of hearing exams without connection to Wi- Fi to include troubleshooting of test administration.

9. Secure Database/Cloud of audiogram records retention and access

10. Incorporation of Employee Baseline Audiogram to the system.

11. Equipment Life Cycle: Must maintain compliance with ANSI S3.6 standards for annual calibration and must include hardware/software upgrades as required by manufacturer.

To maintain stander with ANSI S3.6 annual calibration is required at no additional cost to FSIS. Faulty hardware shall be replaced at no cost to FSIS due to normal wear and tear.

12. Breakdown of Audiological and other Professional support services to include troubleshooting of instrumentation and software.

a. Audiology Services includes:

– Assessment of all audiograms for validity and completeness

– Additional review for shifts & problem audiograms within 5 business days of test

– Identify the need for retests as required

– Provide recommendations for medical and audiological referrals

– Ongoing data quality control/baseline updates

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– Assess/reclassification for hearing changes not related to noise or work exposure

– Up to 1 hour per month of consultation/questions/emails/extra data analysis to the Audiology Team

– 48-hour response time for clinical questions (Mon-Fri 9am-5pm ET)

– Audit support as needed

– Delivery of an Annual Audiology Services Summative Report from the Supervising Audiologist(s)

b. Professional Services include:

– Primary Professional Services representative responsible for knowledge expertise, system configuration, and training during Onboarding for your account

– Virtual training delivery for FSIS

– General technical and customer support services during Phase In

– Import and data quality control of FSIS records

– Deployment management and fleet optimization

– Portal or Database Configuration (portal set up, device settings, projects, etc.)

– Check-in meetings as needed

G. IT Systems and Data Requirements:

1. Compliance with standards and guidelines from the Federal Information Security Modernization Act (FISMA) of 2014, and adherence to National Institute of Standards and Technology (NIST) Special Publication 800-53 Revision 5 standards and guidelines (ex., scanning of laboratory equipment every 72 hours for security vulnerabilities, mitigation of identified critical security risks in 14 calendar days, and 30 calendar days for non-critical vulnerabilities).

2. Compliance with applicable Privacy Act Laws of 1974 regulation to safeguard all sensitive and confidential information, including personally identifiable information

(PII).

3. Implementation of access controls to safeguard confidentiality of sensitive data and systems to ensure only authorized individuals have access. The access controls shall be reviewed semi-annually and revised if necessary, by FSIS in order to confirm access is granted only to authorized individuals and to the extent required to perform the job functions and obligations set forth in the SOW and Contract.

4. Adherence to NIST 800-53 Rev 5 security and HSPD-12 standards to ensure adequate security measures are enforced for remote access, including multifactor authentication and encryption in accordance with.

5. Comply with USDA policy for security awareness training for all employees and contractors who have access to sensitive data.

6. Compliance with organization policy regarding the implementation of incident response procedures to address security incidents, including breach notification requirements.

7. Regular security audits and assessments to ensure ongoing compliance with security control requirements.

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H. Contractor Privacy Act Requirements

1. The Contractor shall incorporate the following into the software prior to self-administering the audiogram:

Privacy Act Statement

The following information is provided in accordance with 5 U.S.C. § 552a(e)(3) and M-03- 22.

Authority: This information is collected under the authority of 5 U.S.C § 301, 44 U.S.C. § 3101, Public Law 107-347, and OSHA 29 CFR 1910.95.

Purpose: The information collected is used to monitor occupational noise exposure and the efforts include location monitoring, training and testing of personnel.

Routine Uses: The information will be used for the purpose of compliance with OSHA safety regulations and as published in the Federal Register as System of Records Notice OPM/GOVT-10. Additional disclosures are outlined in Office of Management and Budget (historical) Circular A-108 in F.R. Vol. 40, No. 132 at 28949, Circular A-108 Reissuance, and in greater detail with commentary on the Department of Justice website OVERVIEW OF

THE PRIVACY ACT OF 1974.

Participation: Personnel may decline to participate in the annual free hearing/audiology test.

System of Records Notice: see OPM GOVT-10

2. Privacy Act Requirements

If performance of this contract has been determined to involve the design, development, or operation of a system of records on individuals, the contractor shall comply with the Privacy Act of 1974, and complete all USDA Privacy Impact Assessment requirements as requested by the contracting officer representative.

For contracts subject to the Privacy Act of 1974, the contractor shall support a system of records in accordance with any Privacy Impact Assessments (PIAs) required and generated by any Privacy Threshold Analyses (PTAs), and any applicable System or Record Notices (SORNs), in conjunction with the judgment of the SAOP, and NARA-approved records schedule(s) and protection requirements for federal agencies to manage their electronic records in accordance with 36 CFR § 1236.20 & 1236.22 (ref. a), including but not limited to maintenance of links between records and metadata, and categorization of records to manage retention and disposal, either through transfer of permanent records to NARA or deletion of temporary records in accordance with NARA- approved retention schedules. The contractor shall comply with the following:

Federal Policies

The contractor shall comply with applicable federal laws that include, but are not limited to, USDA cybersecurity policies, and USDA's Policy Framework Instructions I Standards documents, based on the National Institute of Standards and Technology (NIST) "Framework for Improving Critical Infrastructure Cybersecurity," the Federal Information Security

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Modernization Act (FISMA) of 2014, (44 U.S.C. 101); National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53, Security and Privacy Controls for Federal Information Systems and Organizations; Office of Management and Budget (0MB) Circular A-130, Managing Information as a Strategic Resource; and other applicable federal laws, regulations, NIST guidance, and Departmental policies

3. USDA IT Security Privacy Language

In accordance with the Federal Information Processing Standards Publication (FIPS) 199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor shall: “Comply with the Privacy Act requirements, the Federal Information Security Modernization Act (FISMA) and the OMB Memorandum M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information

OMB Memorandum M-17-12 states:

An agency may also require the contractor to notify any individuals potentially affected by a breach, as explained in this Memorandum. In those instances, the agency may require the contractor to take countermeasures to mitigate the risk of harm to potentially affected individuals or to protect PII on behalf of the agency, including operating call centers and providing resources for potentially affected individuals.

The agency shall ensure that any required countermeasures are consistent with OMB Memorandum M-16-14, which, except under limited circumstances, requires the use of General Services Administration's (GSA) identity protection services (IPS) blanket purchase agreements (BPAs). 37 GSA has awarded government-wide Federal Supply Schedule BPAs for identity monitoring, credit monitoring, and other related services. These BPAs, the requirements for which were developed jointly with officials from the Office of Personnel Management, the Department of Defense, and other agencies, give Federal agencies access to a vetted pool of well-qualified contractors capable of providing the comprehensive services needed to mitigate the risk of harm to individuals potentially affected by a breach, as well as other personnel security matters.

4. Liquidated Damages

This contract is subject to USDA’s IT Security Privacy Language policy requirements that states Contractors shall Comply with the Privacy Act requirements, the Federal Information Security Modernization Act (FISMA) and the OMB Memorandum M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information. Based on the determinations of the risk analysis pertaining to the breach, the contractor shall be responsible for paying to USDA liquidated damages in the total amount incurred from services offered to individuals in the event of data breach.

I. Recordkeeping, Reports, and Records Disposition

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1. 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 that includes:

(a) Employee’s name

(b) Employee’s date of birth

(c) Employee’s Gender

(d) Job classification as of date of most recent audiogram

(e) Date and time of test

(f) Examiner’s name

(g) Date of last acoustic or exhaustive calibration of the audiometer

(h) Evaluation comment

(i) Hearing thresholds

(j) Brief indication of any significant problems noted by employee at time of test

2. The record keeping database/portal must be able to access audiograms by District Office/establishment location or by individual name. Please see below requirements needed:

- Web portal, accessible from browser

- Automatic back up from tablet-based audiometer device

- Secure, HIPAA-compliant storage services

- Centrally view the patient / employee data & results synced from tablet-based audiometer device in logical groupings (geographies, organizations)

- Flexible search and filter capabilities for viewing data

- Electronic data transfer and export of patient test results

- Easy import of patient lists from external sources for download to single or multiple tablet-based audiometer device

- Easy import of historical audiograms, including baselines

- Organize data on the database/portal with the capability to synchronize patient lists to the tablet-based audiometer device

- Define and maintain audiometric baselines for each patient

- Monitoring for threshold shifts for a variety of different regulations/standards

3. Test result shall be populated immediately after completed testing. 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). All original documents shall be recorded and filed separately for a permanent second record in the event of lost records. The naming convention for records shall be: Last Name_First Name_Last 4. All documents, including the electronic files, are the property of and shall be returned to the FSIS. The comprehensive report shall include the below:

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- Individual patient summary reports

- Clinical hearing threshold shift reports (CTCAE, Brock)

- Employee / patient roster reports

- Hearing conservation shift reports following OSHA guidelines

- Test schedule reports including baseline tests, annual tests, and retests

4. The contractor shall provide tabular or charted summaries of the audiometric test data to the COR for review within 30 calendar days of the original audiometric test date. The reports shall provide an analysis of the test results relative to the latest OSHA criteria for STSs. The tests shall be classified and reported according to hearing sensitivity. The audiograms shall be evaluated in accordance with standard audiological practice for further follow-up examination (e.g., suspected conductive losses). All employee audiograms and records shall be handled in accordance with Privacy Act requirements.

5. For each test performed, a summary report shall be provided which provides written notification of the test results for each employee tested. The notification shall provide a written description of the status of the employee’s threshold sensitivity as measured on the most recent audiometric test to that of the most recent baseline. Additional evaluation and referral shall be indicated when appropriate.

6. 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.

7. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the contractor shall provide all required documentation, as specified by the Program Office, to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88 Rev 1, Guidelines for Media Sanitization.

J. Meetings

1. Post-award Kickoff Meeting: Within 7 business days of contract award, the Government will conduct a post-award kickoff meeting online via video teleconference using Microsoft Teams to discuss the coordination and logistics of equipment shipping, initial phase-in training, and other potential startup requirements.

2. Intermittent Project Status Reviews: At the sole discretion of the Government, intermittent project status reviews may be conducted on an informal basis by video teleconference using Microsoft Teams. The Government anticipates no more than two intermittent project status reviews per month.

3. Quarterly Project Reviews: The Government will program management reviews via video teleconference to review the progress of the program, identify any risks, issues, or concerns, and provide feedback on the Contractor’s progress and performance.

K. Required Travel and Other Direct Costs (ODCs)

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There is no anticipated travel for this requirement. The Other Direct Costs (ODCs) that are applicable to this requirement are for equipment calibration and/or shipping of equipment.

L. Government Furnished /Information

The Government will provide the Contractor with a secured cloud/portal to access employee baseline audiograms.

M. Excusable Delay

The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

N. Changes

Changes in the terms and conditions of this contract may be made only by written agreement between FSIS and the Contractor.

O. Transition/Phase-In and Phase-out Periods

Transition Phase-In and Phase-Out Periods. If a non-incumbent is the successful offeror, the non-incumbent shall be required to use the government designated Transition/Phase-In period of no more than 30 calendar days to familiarize itself with the contractual obligations and requirements in preparation for total assumption of responsibilities. Phase-In shall be in accordance with the requirements of the solicitation, and the non-incumbent's approved Phase-In Plan which must be submitted with its proposal.

Accordingly, at the end of the contract, a Transition/Phase-Out Period of no more than 30 calendar days may also be required for the same purpose. During any Phase-out period, the incumbent contractor will support the Phase-In Period of a non-incumbent contractor, as needed, within the incumbent's Contract Statement of Work requirements.