SOW - Cardiac Monitoring - Revised 2nd time .pdf

Department of Health and Human Services Indian Health Service Pawnee Indian Clinic

Statement of Work (SOW) Cardiac Holter and Event Monitors

1. PURPOSE OF THE PROJECT

The Pawnee Indian Health Center (PIHC), Indian Health Services (IHS) has a requirement for cardiac Holter monitors and event monitors. Each year PIHC Cardiology Department provides services of 24- 48 Holter monitoring to patients and event monitors to numerous patients. To ensure a high level of care, PIHC intends to purchase monitors, software, and accessories to quickly and efficiently treat cardiologic patients in-house.

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

The contractor shall provide the following:

1. 24-48 Hour Holter Monitors and/or up to 30 day event monitors.

2. Mobile Cardiac Telemetry Monitors

3. Software to download and process from the monitors

• Time from data ingest to processed information should be less than 1 hour

• When updates to the analytical software are available that are designed to improve the performance of the system, those updates shall be made available PIHC at no additional costs.

• Software can be either local software or online o If data is transferred, contractor will be HIPAA compliant and ensure data is transferred securely and accurately to PIHC.

4. Accessories required to use monitors

• Accessories to be proposed should be adequate to treat approximately 250/150 patients per year

• Example accessories would be adhesive to adhere leads or the monitor to the patient

• Including, but not limited to additional leads and adhesive

5. Interpretation of data with full report

• Contractor shall electronically post the data, analysis, and interpretation for review by the appropriate Pawnee Indian Clinic Staff.

Product Specifications

Holter and Event Monitoring The contractor shall provide monitoring devices that can perform functions cardiac event and Holter monitoring for patient care. The monitors will provide the following:

Monitors that are ordered for the patient’s specific needs.

• Bidirectional communication between our EMR(CPRS) and the contractor is highly desirable

• Ability to store 100% of the ECG data in the device(s); no event can be lost due to memory limitations.

• ECG analysis to have a minimum of 3 leads, up to 6 leads (views) with no more than 3 electrodes.

• Ability to analyze all ECG data over the monitoring period. ECG data is uploaded to the computer and analyzed.

• Contractor shall post an all-results-data export file encoded as either XML or HL7.

• Ability to post an End of Study compiling all Event and Holter ECG data into one conclusion report.

• Holter Monitoring: All ECG data will be analyzed following transmittal to contractor as both a quality control and to provide comprehensive reporting to physician. Holter monitor(s) will include full disclosure reports. Holter reports shall be standard Holter reports and shall include:

• Heart Rate ECG data including: Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, total number of Analyzed Minutes, total number of minutes in Sinus Bradycardia /Tachycardia and longest episode of each, total Pauses in excess of 2 seconds and max pause.

• Total number of VE’s (Ventricular Ectopy)Ventricula, V-Pairs, V-Runs, Longest V-Run, Maximum and Minimum HR V-Run (if applicable), VE’s per 1000/per Hour ratio, and Ventricular R on T.

• Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable), SVE’s per 1000/per Hour ratio.

• Atrial Fibrillation / Flutter: Burden, Total number of minutes in A-Fib, Number of Episodes, A- Fib graph.

• ST Segment Analysis: Max ST Depression and Elevation, Total number of ST minutes, Max ST Episode, and Max HR in ST Episode.

• QT Analysis: When applicable, Max QT and QTc.

• Heart Rate Variability: Time Domain and Spectral Power.

• Full Disclosure capability.

End of Study Reports All ECG data (exceeding 48 hours) will be compiled into an End of Study to provide comprehensive reporting to physician. End of Study ECG report shall include at minimum:

Comprehensive compilation of Heart Rate ECG data over the entire monitoring period including:

Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, Total number of Analyzed Minutes, Total Pauses in excess of 2 seconds and max pause. Representative strips shall be provided.

• Total number of VE’s, V-Pairs, V-Runs, Longest V-Run, Maximum HR V-Run (if applicable).

• Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable).

• Atrial Fibrillation / Flutter: Burden, Minimum, Maximum and Average HR, and Longest episode.

• Full Disclosure capability.

• Description of all events, both patient-triggered and automatic (in response to rhythm and/or

Heart rate meeting programmed criteria), including date/time stamp, symptoms reported, tracing, preliminary interpretation.

Procedure

The device(s) is given to patients to use for 1 to 30 days depending on the indication for the Cardiac/Telemetry monitoring. Upon receipt of an order, PIHC staff will schedule an appointment.

They will instruct and explain to the patients about what the device(s) is and how to use it. This will be done while at the PIC facility. They will then hook up the device(s) to the patient, with specific instruction in order to continue to have the device(s) on for the duration of evaluation. After the evaluation period, the patient returns the device(s) to PIC. It will then be downloaded and electronically sent to contractor for processing and interpretation (unless specified). Contractor shall electronically post the data, analysis, and interpretation for review by the appropriate Pawnee Indian Clinic Staff within 1 hour of receipt. PIC will provide afterhours emergency contact numbers for the clinic. Reports may be sent to PIC via fax and mail as a contingency method.

Instrument Capabilities

• Instruments should include a wireless waterproof patch recorder.

• Pacemaker pulse detection.

• Contractor equipment shall be capable of storing up to thirty-days (30) of all ECG data, using standard size batteries readily available, and easily changed by the patient.

Additional Details

• There is allowance for a one-time perpetual license or a yearly licensing fee, but they shall be proposed clearly in the proposal.

• Both models of monitors shall have a minimum of a one-year warranty.

3. PERIOD OF PERFORMANCE

The base year Period of Performance will be 12 months from date of award with four (4) twelve (12) month option years.

4. LEVEL OF EFFORT

4.1. The contractor shall provide reference resources to assist PIHC staff in interfacing with the monitors and resources.

4.2. The contractor shall provide customer notifications and latest operator’s manual within 10 days after their release/publication.

4.3. Training: Contractor shall provide training on the use, maintenance, and cleaning of the monitors and software to the cardiologist and assisting nurse. After initial training, there shall be training provided if there are updated or changes to the software.

5. SPECIAL REQUIREMENTS

5.1. In accordance with HHSAR 304.1300(b) non-routine contractor employees shall comply with

OPDIV DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for contract performance period. Contractor employees will be required to obtain a visitor’s pass upon arrival for services from Facilities Management.- (Security Clearance for on-site human services)

5.2. The USPHS Pawnee Indian Clinic is a tobacco/smoke free environment (buildings and grounds).

No tobacco/smoking use will be tolerated during service.

5.3. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by Pawnee Indian Clinic official, presenting valid identification, smoking restriction and any safety procedures.

5.4. The contractor shall not disclose or cause to disseminate any information concerning operations of Pawnee Indian Clinic. Such action(s) could result in violation of the contract and possible legal actions.

5.4.1. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the government’s designated representative.

5.5. Termination Amortization Schedule: A termination amortization schedule shall be included as an attachment of the awarded contract. If the Government does not exercise any of the options listed in the price / cost schedule, the Government’s not exercising the options will have the same effect as if the Government terminated for convenience. All remedies afforded to contractor in regards to a termination for convenience shall be available to the contractor.

5.6. The contractor shall comply with the following listed regulations:

5.6.1. Privacy Act, 5 U.S.C. 552a - Office of Privacy and Civil Liberties | Privacy Act of 1974

5.6.2. Health Insurance Portability and Accountability Act (HIPAA) - eCFR :: 45 CFR Part 164 --

Security and Privacy

5.6.3. CFR 42 Part 2 - eCFR :: 42 CFR Part 2 -- Confidentiality of Substance Use Disorder

Patient Records

5.7. Indemnification and Governing Law:

Indemnification, Liability, Statute of Limitations: Any provisions in the Terms of Service (TOS) related to indemnification and filing deadlines are hereby waived, and shall not apply except to the extent expressly authorized by law. Liability for any breach of the TOS as modified by this amendment, or any claim arising from the TOS as modified by this amendment, shall be determined under the Federal Tort Claims Act, or other governing federal authority. Federal statute of limitations provisions shall apply to any breach or claim.

https://www.justice.gov/opcl/privacy-act-1974 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164 https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-2 https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-2

Governing law: Any arbitration, mediation or similar dispute resolution provision in the TOS is hereby deleted. The TOS and this amendment shall be governed by and interpreted and enforced in accordance with the laws of the United States of America without reference to conflict of laws.

To the extent permitted by federal law, the laws of the State of Oklahoma will apply in the absence of applicable federal law.

5.8. Section 508 and Accessibility

• This product must conform to the Revised Section 508 (https://www.access-board.gov/guidelines-andstandards/communications-and-it/about-the-ict-refresh/finalrule/text-of-the-standards-and-guidelines) and WCAG 2.0 Level AA standards as outlined below.

• Solicitations for supplies and services shall require the submission of a Section 508 Product Assessment Template. The template can be found at https://www.itic.org/policy/accessibility/vpat.

5.8.1. 352.239-73 Electronic Information and Technology Accessibility Notice.

(a) As prescribed in HHSAR 339.203-70(a), the Contracting Officer shall insert the following provision:

Electronic and Information Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508.

The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-andstandards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility. In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 http://www.access-board.gov/guidelines-andstandards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-andstandards/communications-and-it/about-the-section-508-standards accessibility standard, and any underway remediation efforts addressing conformance issues.

Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

Standards

The included standards that must be met for this contract are taken from the following two resources. Compliance with these standards is mandatory for Federal agencies subject to Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d).

• Section 508 Standards and Guidelines: https://www.access-board.gov/guidelines-andstandards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

• Web Content Accessibility Guidelines (WCAG) 2.0: https://www.w3.org/TR/WCAG20/

Electronic content must be accessible to HHS acceptance criteria

Checklist for various formats are available at http://508.hhs.gov, or from the IHS Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html, (email: IHSSection508@ihs.gov). Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Electronic Content Accessibility - Web Based

• 602 Support Documentation

• 603 Support Services

• All WCAG A & AA Success Criteria

Electronic Content Accessibility - Non-Web Based

• 602 Support Documentation

• 603 Support Services

• All WCAG A & AA Success Criteria apply except:

o 2.4.1 Bypass Blocks o 2.4.5 Multiple Ways o 3.2.3 Consistent Navigation o 3.2.4 Consistent Identification http://www.hhs.gov/web/508 https://www.w3.org/TR/WCAG20/

Software Accessibility - Non-Web Based

• All WCAG A & AA Success Criteria apply – EXCEPT the following:

o 2.4.1 Bypass Blocks o 2.4.5 Multiple Ways o 3.2.3.Consistent Navigation o 3.2.4 Consistent Identification

• 502 Interoperability with Assistive Technology

• 503 Application

• 602 Support Documentation

• 603 Support Services

• 302 All Functional Performance Criteria - Note: Applies when Chapter 5 does not address one or more functions of ICT (E204), or when an agency invokes "equivalent facilitation" (E101.2)

Hardware Accessibility

• 404 Preservation of Information Provided for Accessibility

• 405 Privacy

• 406 Standard Connections

• 407 Operable Parts

• 409 Status Indicators

• 410 Color Coding

• 411 Audible Signals

• 602 Support Documentation

• 603 Support Services

• 302 All Functional Performance Criteria - Note: Applies only when Chapter 4 does not address one or more functions of ICT (E204), or when an agency invokes "equivalent facilitation" (E101.2))

For Hardware that has closed functionality include

• 402 Closed Functionality

For Hardware with display screens include

• 408 Display Screens

For Hardware with multimedia include

• 413 Closed Caption Processing Technologies

• 414 Audio Description Processing Technologies

• 415 User Controls for Captions and Audio Descriptions

Support Documentation Accessibility

• E602.1 General - Documentation that supports the use of ICT shall conform to 602.

• E602.2 Accessibility and Compatibility Features - Documentation shall list and explain how to use the accessibility and compatibility features required by Chapters 4 and 5.

Documentation shall include accessibility features that are built-in and accessibility features that provide compatibility with assistive technology.

• E602.3 Electronic Support Documentation - Documentation in electronic format, including Web-based self-service support, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

• E602.4 Alternate Formats for Non-Electronic Support Documentation - Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

• E602.3 Electronic Support Documentation - Documentation in electronic format, including Web-based self-service support, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

• E602.4 Alternate Formats for Non-Electronic Support Documentation - Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

• E603.1 General - ICT support services including, but not limited to, help desks, call centers, training services, and automated self-service technical support, shall conform to 603.

• E603.2 Information on Accessibility and Compatibility Features - ICT support services shall include information on the accessibility and compatibility features required by 602.2.

• E603.3 Accommodation of Communication Needs - Support services shall be provided directly to the user or through a referral to a point of contact. Such ICT support services shall accommodate the communication needs of individuals with disabilities.

• WCAG – All WCAG 2.0 A & AA Success Criteria

EXCEPTION:

o Non-Web documents shall not be required to conform to the following four WCAG 2.0 Success Criteria: 2.4.1 Bypass Blocks, 2.4.5 Multiple Ways, 3.2.3 Consistent Navigation, and 3.2.4 Consistent Identification.

o E205.4.1 Word Substitution when Applying WCAG to Non-Web Documents. For non- Web documents, wherever the term "Web page" or "page" appears in WCAG 2.0 Level A and AA Success Criteria and Conformance Requirements, the term "document" shall be substituted for the terms "Web page" and "page". In addition, in Success Criterion in 1.4.2, the phrase "in a document" shall be substituted for the phrase "on a Web page".

• Appendix A – Section 508 of the Rehabilitation Act: Application and Scoping Requirements o E208 Support Documentation and Services

• Appendix C – Functional Performance Criteria and Technical Requirements o 302 - Functional Performance Criteria o 602 – Support Documentation o 603 – Support Services

Functional Performance Criteria

• 301.1 Scope - The requirements of Chapter 3 shall apply to ICT where required by 508 Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255 Guidelines.

• 302.1 Without Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that does not require user vision.

• 302.2 With Limited Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited vision.

• 302.3 Without Perception of Color - Where a visual mode of operation is provided, ICT shall provide at least one visual mode of operation that does not require user perception of color.

• 302.4 Without Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that does not require user hearing.

• 302.5 With Limited Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited hearing.

• 302.6 Without Speech - Where speech is used for input, control, or operation, ICT shall provide at least one mode of operation that does not require user speech.

• 302.7 With Limited Manipulation - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that does not require fine motor control or simultaneous manual operations.

• 302.8 With Limited Reach and Strength - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that is operable with limited reach and limited strength.

• 302.9 With Limited Language, Cognitive, and Learning Abilities - ICT shall provide features making its use by individuals with limited cognitive, language, and learning abilities simpler and easier.

6. DELIVERABLES AND REPORTING REQUIREMENTS

6.6. Delivery: The contractor will coordinate the delivery, installation and training date with the designated government employee. The government will provide the contractor with dock access and building access for this sole purpose. The designated government employee will work with the pertinent government agency(ies) to secure the needed dock access. No deliveries can be made after 4:00pm. Driver needs a valid ID.

6.7. Contractor Point of Contact: The contractor shall furnish one designated point of contact

(POC) to the government’s designated representative for coordination of supplies, delivery, and/or maintenance. The POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

6.8. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 4:30 pm, Monday through Friday.

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

7.6. The Government shall supply a computer to ingest the data and process if done locally.

There is no other government property, facilities, or services provided.

8. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

8.6. Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract.

8.6.2. All equipment offered shall be U.S. Food and Drug Administration (FDA) approved.

8.6.3. All cardiac event and Holter monitors shall be provided by the contractor for Pawnee Indian

Clinic use and shall be lightweight and simple for patients to use. Patients will use the monitors for one (1) to thirty (30) days, or as specified by the PIHC provider. Samples shall be provided to each site during the training or orientation process.

9. CHANGES TO THE STATEMENT OF WORK (SOW)

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

10. DELIVERABLES/PERFORMANCE MATRIX

10.6. Provided required cardiac monitors on time and in satisfactory condition : Yes No

10.7. Reports were provided promptly: Yes No

10.8. Training was provided: Yes No

10.9. Asymptomatic events were reported as needed: Yes No

Department Supervisor Signature:_________________________

Chief Operating Officer Signature:_________________________