11-18-2020 Draft Performance Work Statement SS Post.pdf

PERFORMANCE WORK STATEMENT

Intraoperative Neuromonitoring (IONM) Services Dwight D. Eisenhower Army Medical Center (DDEAMC)

Fort Gordon, GA 30905

1.0 Introduction.

1.1 The Contractor shall provide services to notify the surgeon of potential injury to vital neural structures while the patient is under anesthesia during spinal surgeries. This contract is a non-personal services contract under which the Contractor personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

Intraoperating Neuromonitoring (IONM) is the continuous surveillance of a patient's nervous system (the brain, spinal cord, and nerves) when it can be at risk of injury during surgery. The purpose of IONM is to protect the nervous system and to provide an extra layer of safety for both the surgeon and patient. This reduces the risk to the patient of iatrogenic damage to the nervous system, and/or to provide functional guidance to the surgeon. This service is designed specifically to notify the surgeon of potential injury to vital neural structures at times when a clinical examination is not possible while the patient is under anesthesia. A qualified, trained surgical neurophysiologist Contractor employee will perform electrophysiological methods such as electroencephalography (EEG), electromyography (EMG), and evoked potentials to monitor the functional integrity of certain neural structures (e.g., nerves, spinal cord and parts of the brain) in support of the DDEAMC surgeon(s) within the facility operating room suite. The goal of this service is to improve patient care, safety and overall clinical outcomes. The Dwight D.

Eisenhower Army Medical Center (DDEAMC) in Fort Gordon, GA is seeking a Contractor that can meet/exceed the Government’s objectives for Complete Intraoperative Neuromonitoring Services. The Contractor will be required to provide the personnel, equipment, labor, materials, accessories, and supplies necessary for performance. The IONM services include complex spinal surgical procedures which are done during scheduled timeframes and during emergencies 24 hours a day, 7 days a week, & 365 day a year.

2.0 General.

2.1 Professional Liability

The Government will not be liable for malpractice allegations against Contract Healthcare Provider’s (HCP) based upon performance of this contract. The Contractor shall be required to carry malpractice insurance for its contract HCPs, at a level stated in the solicitation and included in any resulting contract for subject acquisition in tailored Federal Acquisition Regulation (FAR) Clause 52.237-7. Upon contract award, the Contractor shall provide evidence of insurance demonstrating the required coverage prior to commencement of performance. In accordance with FAR Clause 52.237-7, the Contractor will indemnify the Government for any liability producing act or omission by the Contractor, its contract HCPs, and agents occurring during contract performance. If the Contractor uses subcontractors in the performance of this contract, the Contractor is required to ensure that its subcontracts for provisions of healthcare services contain the requirements of FAR 52.237-7 including the maintenance of medical liability insurance.

2.2 Responsibility and Procedures

If any suit or action is filed or any claim is made against the contract HCP, which occurred as a result of work performed by the HCP under this contract, the HCP shall immediately notify the Contractor and the Contracting Officer and the Chief of the appropriate services and promptly furnish them copies of all pertinent papers received.

2.3 The Contractor’s Qualified Healthcare Provider employee(s) shall provide an onsite medical staff whose qualifications are derived from an accredited learning institution (United States Professional Accreditation Standards) with professional credentials as a Certified Neurophysiological Intraoperative Monitoring (CNIM) and currently licensed to practice in the State to include certification by the American Board of Neurophysiologic Monitoring (DABNM).

The Contractor employee’s clinical competence shall conform to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards. The Contractor shall also possess accreditations and certifications from The Joint Commission (TJC). All Contractor’s employee shall perform in accordance with clinical standards and the terms outlined in the PWS. All Contractor’s employee(s) shall perform within their individual scopes of practice/privileging. Patient safety incidents shall to be reported using Patient Safety Reporting. All incidents shall be reported immediately (within 24 hours.). Updated licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

2.4 Place of Performance: Dwight D. Eisenhower Army Medical Center (DDEAMC), Fort Gordon, GA.

2.5 Performance period includes a base contract and four one-year options starting at contract award.

3.0 Scope.

The Contractor shall provide onsite Intraoperative Neuromonitoring support services (estimated two-hundred surgical cases per year) to the surgeon(s) within the operating room suite at the Dwight D. Eisenhower Army Medical Center (DDEAMC) to include:

• Mandatory Contractor certification in Neurophysiologic Intraoperative Monitoring

(CNIM).

• Certification by the American Board of Neurophysiologic Monitoring (DABNM)

• Have a minimum of five (5) years of experience.

• Both the Joint Commission on Accreditation of Healthcare Organizations and the Joint

Commission Accreditation.

• Collaboration and continual engagement with surgeons and anesthesiologists.

• A proven research track record.

• Continuous coverage 24 hours/7 days/365 a year, typically within a thirty minute notification (onsite technical and online professional services) period.

• Clinical liability insurance for all contracted clinicians.

• Comprehensive multi-modality approach to nervous system monitoring.

• Skill set verification, testing, evaluations and required training prior to providing neuro-monitoring services.

• Fee schedule including pricing for the base year and all options for IONM services.

• Availability within a fifteen (15) mile radius and a thirty minute (30) for rapid response time.

• Service Agreement (Warranty) for the base year and all options.

4.0 Deliverables

4.1 Medical Services. The Contractor shall provide a billing sheet (usage form) after the procedure has been performed, which outlines the provided services.

4.2 Complete Intraoperative Neuromonitoring (IONM) Services. The Contractor shall provide real-time data. The Contractor will offer the most recent technology and hardware that efficiently allows for the transfer of data into the patient’s Electronic Medical Records. The Contractor will work closely with the surgeons, nursing staff, schedulers, and other associated clinicians. It is essential that the proposed operating system integrates into existing infrastructures and exchanges data with other systems using common standard interfaces. The Contractor shall provide a surgical system that has the ability to function with the current power (electrical) supply. The Contractor shall provide real-time monitoring via HIPPAA & HITECH (or similar) compliant. The Contractor shall provide scheduled services throughout the contract period. In the event of the absence of Contractor’s personnel for any reason, the Contractor shall provide replacement personnel to provide the scheduled services within twenty-four (24) hours. All and any replacement personnel must meet the credentialing & privileging requirements prior to providing care to DDEAMC patients. Finally, the Contractor will provide a Quality Assurance plan that monitors, track any successes or complications, and trends that are reported quarterly.

4.3 Program Management and Contractor Qualifications. The Contractor shall provide all project management services under this contract. Project management services are assumed by the Government to be integral and inherent in the performance of all service tasks of this contract. As such, the project management services under this contract should be factored into the price of other services and not as separate CLINs on this contract. The Contractor shall provide a draft comprehensive management plan with the proposal that includes all items necessary for the successful completion of this project. Face‐to‐face installation meetings and related activities shall begin within 30‐days of contract award and shall be conducted at DDEAMC offices.

4.3.1 The Contractor shall provide, transport, install, participate in the simulations, be available in live surgical cases, and test the medical equipment prior to utilization.

4.3.2 All equipment and installation must meet manufacturers and DDEAMC specifications.

The Contractor will ensure that equipment is inspected each time it enters the medical facility.

4.3.3 The Contractor shall furnish all supplies, accessories, equipment, consumables, transportation, delivery, training, and services. The Contractor shall submit its billing sheet via e-mail to the Contracting Officer Representative or Contracting Officer authorized official.

Contractor shall provide invoices thirty (30) days post procedure in Procurement Integrity (PIEE) system formerly known as Wide Area Work Flow.

4.3.4 The Contractor is responsible for any missing parts and components to complete the requested service.

4.3.5 The Contractor must be accredited and certified by The Joint Commission.

4.3.6 The Contractor will ensure that all professional staff have the necessary licenses and certifications. Must have CNIM – Certified Surgical Neurophysiologists.

4.3.7 The Contractor shall provide the necessary personnel to service more than one surgical operation simultaneously, if required.

4.4 Hardware Upgrades. The Contractor shall ensure all equipment is up to date with modern technology and hardware. If hardware upgrades become available after award of this contract but prior to installation of the equipment, the Contractor shall offer the upgrades to the Contracting Officer for consideration.

4.4.1 The equipment shall be FIPS 140-2 compliant.

4.4.2 The laptop shall be encrypted and password protected to FIPS 140-2 encryption standards.

4.5 Service Agreement (Warranty). The Contractor shall provide a full-service plan that covers the all IONM surgical procedures. The service plan should include:

• A method that minimizes the amount of time delay between surgical procedures.

• On-site and offsite personnel 24/7/365 that includes emergencies for requested surgical procedures. The Contractor shall be responsible for all preventative maintenance of the medical equipment.

4.6 Acceptance. The Government will survey patients treated by the Contractor on an ongoing basis. Services that are not acceptable will be identified to the Contractor. The Contractor shall not have more than two complaints per month. FAR 52.246-4 applies to inspection of services and remedies for non-conforming work performance.

5.0 Government Furnished Property and Services. The Government will not provide any equipment, supplies and services.

6.0 Contractor Furnished Items and Services. The Contractor shall furnish everything required to perform the services this contract.

7.0 Performance Criteria. The Contractor shall identify all places of performance (e.g., onsite,).

8.0 Security. Contractor personnel do not require a security clearance. However, they must be able to gain and maintain access to the installation.

8.1 Information Security. All contract personnel shall comply with DOD, DA, and the Medical Command policies, regulations, and directives concerning the security of information and information systems. All financial, statistical, personnel, and/or technical data that are furnished, produced, or otherwise made available to the Contractor or its personnel are considered confidential and proprietary and shall not be used for purposes other than the performance of work under this contract. The Contractor’s personnel shall release none of this information.

9.0 Level of Effort. The level of effort is based upon emergent and/or scheduled surgeries by the DDEAMC employee(s)(s). As a result, the Government cannot provide an estimate of when services will be required. Contractors will constantly review their performance based on meeting the Army's regulatory requirements for Intraoperative Neuromonitoring.

10.0 Contracting Officer Authority. The Contracting Officer is the only person authorized to make or approve changes in any of the requirements of this contract.

11.0 Contract Administration. Unless otherwise stated herein, all correspondence concerning this contract issued hereunder will be directed to the Contracting Officer Representative and Contracting Officer for the applicable Army installation.

12.0 Contractor Responsibility. The Contractor shall begin full performance of the contract requirements as stated in the Performance Work Statement. The Contractor shall not employ Active Duty Military nor Government civilian employees to perform services under this contract.

13.0 Applicable Publications, References and Regulations

a. Army Reference Title

(1) AR 40-68 Clinical Quality Management

(2) AR 40-66 Medical Records, Administration

(3) AR 40-501 Standards of Medical Fitness

(4) DoD Directive The Joint Ethics Regulation (JER) 5500.7R

14.0 Applicable Technical Orders, Manuals, Regulations, Directions and Forms. All applicable directives and publications (advisory or mandatory), and supplements or amendments to these directives and publications will be current when furnished to the Contractor. Directives will be available to Contractor upon request.

15.0 The Contractor is required to follow all mandatory documents to the extent they apply to this contract. Any such changes to mandatory publications that cause a change in the scope of performance will not be implemented by the Contractor until the Contracting Officer issues a modification in writing.

16.0 Glossary of Acronyms

(a) Certified Neurophysiological Intraoperative Monitoring (CNIM)

(b) American Board of Neurophysiologic Monitoring (DABNM)

(c) Intra Operating Neuro Monitoring (IONM)

(d) The Joint Commission (TJC)

(e) Non-Defense Health Portability and Accountability Act (HIPAA)

(f) Department of the Army (DA)

(g) Department of Defense (DOD)

(h) Employee Medical File (EMF)

(i) Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

(j) Medical Treatment Facility (MTF)

(k) Office of Personnel Management (OPM)

(l) Qualified Health Provider (QHP)

17. Attachment/Technical Exhibit List

a. Technical Exhibit 1 Performance Requirement Summary

b. Attachment 1 Quality Assurance Surveillance Plan (QASP)

c. Attachment 2 Past Performance

d. Attachment 3 Price List

e. Attachment 4 Non-Defense Health Agency (NON-DHA) Health Insurance Portability and Accountability Act (HIPAA) Business Associate Agreement (BAA) (7 July 2014) f, Attachment 5 Wage Determination

Technical Exhibit 1

Performance Requirement Summary (PRS) (Deliverables)

Performance Outcomes

PWS

Ref.

Performance

Requirement

Standard Acceptable Quality Level

Remedies

Provider Quality Performance

2.3

All Contractor’s neurophysiologist (s)/ technologist (s) shall perform in accordance with clinical standards and the terms outlined in the PWS.

100% of care provided within clinical standards of care

100% compliance required Document performance in CPARS and a cure notice may be processed.

Patient Access 3.1 All Contractor’s employee(s) All (100%) Contractor’s employee(s) Document performance in CPARS and a cure shall be available as needed to properly perform tasks as specified.and in location as needed.

Contractor’s employee(s) (s) are on time and available to perform services.

are on-time and available to perform services 100% of the time

Patient Safety 2.0 Patient safety incidents shall to be reported using Patient Safety Reporting. All incidents reported immediately (within 24 hours.)

All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident.

100% of patient safety incidents are reported using Patient Safety Reporting within 24 hours of incident.

Document performance in CPARS and a cure notice may be processed.

Maintains licensing, registration, and certification

2.0 Updated Licensing, registration

and certification shall be provided as they are renewed.

Licensing and registration information kept current.

All (100%) licensing, registration(s) and certification(s) for Contractor’s employee(s) (s) shall be provided as they are renewed.

Licensing and registration information kept current.

100% licensing, registration(s) and certification(s) for Contractor’s employee(s)

(s) shall be provided as they are renewed. Licensing and registration information kept current. No acceptable deviation.

Document performance in CPARS and a cure notice may be processed.

Mandatory Training 2.0 Contractor shall complete all required training per Eisenhower ‘s policy

All (100%) of required training is complete on time by Contractor’s employee(s)(s) .

100% completions Document performance in CPARS and a cure notice may be processed.

Privacy, Confidentiality and HIPAA

Attachment

Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality

All (100%) Contractor’s employee(s) (s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA

100% compliance Document performance in CPARS and a cure notice may be processed.

Maintains patient privacy and confidentiality confidentiality

Attachment

Zero breaches of privacy Documented complaints

Documented breaches of privacy

Maintains patient privacy and confidentiality

HIPAA clause

Provide a billing sheet 4.1 Contractor will provide a billing sheet after each service outlining the procedure, modality/description and charges.

All 100% compliance in required documentation.

100% compliance Document performance in CPARS and a cure

Provide proper equipment, utilization and maintenance of equipment

4.3.2, 4.4.1 All Contractor equipment and installation shall meet manufacturers and DDEAMC specifications.

All 100% compliance in required documentation.

100% compliance Document performance in CPARS and a cure notice may be processed.

Provide project management 4.3 Contractor shall provide all project management services under this contract.

All 100% compliance in required documentation.

100% compliance Document performance in CPARS and a cure notice may be processed.

Provide a service agreement/warranty

4.5 Contractor shall The

Contractor shall provide a full-service plan that covers the all IONM surgical procedures

All 100% compliance in required documentation.

100% compliance Document performance in CPARS and a cure notice may be processed.

Provide an invoice 4.3 Contractor submit its invoice thirty (30) after performance service.

All 100% compliance in invoicing.

100% compliance