3 PWS NEUROSURGICAL MONITORING.pdf

B.4 PERFORMANCE WORK STATEMENT (PWS)

INTRA-OPERATIVE NEUROPHYSIOLOGICAL

MONITORING SERVICE

1.0 BACKGROUND:

The Southern Arizona VA Health Care System (SAVAHCS) located at 3601 S. 6th Ave., Tucson, Arizona, has an ongoing requirement for contractor services to provide Intra-operative Neurophysiological Monitoring Services (IONMS). The provided care shall cover the application and interpretation of various electrophysiological and vascular tests for patients with central and/or peripheral nervous systems and/or vascular systems at risk normally provided in a similar civilian health care facility, in accordance with the specifications and requirements contained herein.

2.0 SCOPE:

The Intra-operative Neurophysiological Monitoring Service described in this contract shall be provided by the contractor subject to overall clinical and technical direction by the Southern Arizona VA Health Care System’s (SAVAHCS) Attending, Neurosurgery and Anesthesiologist Surgical Care Line. The contractor and employees shall have a minimum of 5 years’ experience in IONMS services and shall provide all equipment, labor, materials, accessories, and supplies necessary for a Complete Intraoperative Neuromonitoring (IONM) Service that can support any of the SAVAHCS surgical operating rooms in the facility. Clinical and technical direction of contract employees do not include personnel actions such as hiring, firing or job evaluation for pay purposes. Clinical and technical direction does include monitoring quality of care, assignment of cases and assignment of physician and/or technologist supervision duties. Further, the SAVAHCS Chief, Surgical Care Line or delegate retains authority to immediately correct any adverse situation potentially affecting the safety of a VA patient.

2.1 Complete Intraoperative Neuromonitoring (IONM) Service

The Contractor shall be capable of providing real-time data; in addition, the Contractor shall provide the most recent technology and hardware to include internet connection and VPN account. The contractor will not connect to the VA network or have network access to VASI, PI, or PHI. To help understand the patient and correlate data, the contractor will obtain a copy of the history and physical from the circulating nurse prior to procedure. The Contractor will work closely with the surgeons, nursing staff, schedulers, Clinical Engineering, and Sterilization and Processing Service. The online Neurologists will provide real-time monitoring via HIPPAA & HITECH (or similar) compliant telemedicine. 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 bear the responsibility of providing replacement personnel to provide the scheduled services. All and any replacement personnel must meet the Credentialing & Privileging requirements prior to providing care to SAVAHCS’s patients. Finally, the Contractor will provide a complete Quality Assurance program that monitors, track any successes or complications, and trends that are reported to the SAVAHCS’s Surgical Work Group (FSWG) quarterly.

The Quality Assurance Surveillance Plan (QASP) is managed by the Contractor and presented to the

FSWG.

2.2 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. 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 SAVAHCS’s offices.

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

2.4 All equipment and installation shall meet manufacturers and VA specifications. The Contractor shall ensure that Clinical Engineering inspect the equipment each time it enters the medical facility.

2.5 The Contractor shall furnish all supplies, accessories, equipment, consumables, transportation, delivery, training, and services. The Contractor shall use Right Fax to transmit the reports.

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

2.7 The Contractor shall be accredited and certified by The Joint Commission.

2.8 When required, the IONM will support Deep Brain Simulation and Transcranial Doppler cases.

2.9 The Contractor shall ensure that all professional staff have the necessary licenses and certifications.

Must have CNIM – Certified Surgical Neurophysiologists.

2.10 The Contractor shall provide the necessary personnel to service more than one surgical operation simultaneously.

2.11 Standards of Care: Contractor shall be responsible for meeting or exceeding VA and The Joint Commission (or equivalent) standards. The contract personnel’s care shall cover the range of IONM services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized national standards as established by:

2.11.1. American Clinical Neurophysiology Society Recommended Standards for Neurophysiologic Intraoperative Monitoring https://www.acns.org/practice/guidelines.

2.11.2. American Association for Neurological Surgeons Guidelines:

http://aans.org/en/Education%20and%20Meetings/clinical%20Guidelines.aspx.

2.11.3. VA Standards: VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443.

2.11.4. The professional standards of The Joint Commission (TJC) http://www.jointcommission.org/standards_information/standards.aspx.

2.11.5. The standards of the American Hospital Association (AHA) http://www.hpoe.org/resources?show=100&type=8: and

2.11.6. The requirements contained in this PWS.

3.0 REQUIREMENTS:

a. The contractor shall coordinate provision of services with the Chief, Surgical Care Line, or designee. Contractor is responsible for provision of all equipment and supplies in support of the services it provides, including monitoring equipment, internet connection and VPN account.

b. The contractor shall complete all administrative tasks, documentation of patient care and required medical transcription and signature within 24 hours of procedures. The contractor and their employees shall have a minimum of 5 years’ experience with IONMS Services.

c. The contractor shall schedule emergency cases not later than 8 hours after receiving notification. Response time for urgent cases shall be between 8 hours and 24 hours. Response time for routine cases shall be between 24 hours, but not later than 72hours.

d. Complications and/or incidents incurred during the administration of this contract will be reported within 24 hours of discovery to the COR and/or clinical designee and the contractor shall provide SAVAHCS with a complete copy of the medical records for review. This copy is to occur as close to the time of the adverse event as is practicable but NLT 48 hours. Also, contractor is to allow SAVAHCS access to patient records as requested by the SAVAHCS.

e. The contractor agrees to be reimbursed for services in relation to current Medicare rates applicable to the appropriate CPT codes (listed in Schedule) under Medicare Locality Fee Schedule-Arizona Locality 01.

f. The VA Medical Center, SAVAHCS shall establish and maintain a record keeping system that will record the hours worked by the contractor employee(s). Contractor's employee(s) shall report to Surgical Care Line's COR, Anna Malone, or designee upon arrival at the Southern Arizona VA Health Care System.

4.0 CREDENTIALING/PRIVILEGING: Credentialing and privileging are to be done in accordance with the provisions of VHA Handbook 1100.19 utilizing VetPro, a federal web-based credentialing program for healthcare providers. The Contractor is responsible to ensure that proposed employees possess the requisite credentials enabling the granting of privileges. No services shall be provided by any contractor’s employees prior to obtaining approval by the SAVAHCS Professional Standards Board, Medical Executive Board and Medical Center Director. Contractor shall allow a minimum of 90 calendar days for review of credentials by the VA Professional Standards Board and the Director or his/her designee.

a. If contractor’s employees is/are not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

b. The contractor’s employees will be required to report specific patient outcome information, such as complications, to the Service Line Chief. Quality improvement data provided by the employees and/or collected by the Service will be used to analyze individual practice patterns.

The Service Chief will utilize the data to formulate recommendations for the Professional Standards Board to consider in the renewal of clinical privileges.

c. Privileges will require renewal at least every two (2) years in accordance with Medical Center and Joint Commission requirements.

d. Physicians assigned by the contractor to work at the SAVAHCS will be required to report specific patient outcome information, such as complications, to the Service Chief. Quality improvement data provided by the physicians and/or collected by the Service will be used to analyze individual practice patterns. The Service Chief will utilize the data to formulate recommendations for the Professional Standards Board to consider in the renewal of clinical privileges.

4.1 Continuing Medical Education (CME)/Certified Education Unit (CEU) Requirements:

Contractor shall provide the COR copies of current CMEs as required or requested by the SAVAHCS.

Contractor’s personnel registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging.

Failure to provide shall result in loss of privileges for contractor’s physician(s).

4.2 Training (ACLS, BLS, CPRS and VA MANDATORY):

Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contract personnel as required by the VA.

All personnel must have certification in cardiopulmonary resuscitation (CPR) by an American Health Association vendor. Personnel must be able to demonstrate competency in providing CPR and have current basic life support (BLS) certification. Critical care Nurses shall have advanced cardiac life support (ACLS) certification.

Prior to the first day of work, all contractors are required to have completed all necessary TMS training, Finger printing, background check, being PIV sponsored with two forms of approved photo ID’s, having their signature code in the Vista computer system and be fully capable of working and providing patient care.

Training Frequency Annual Hours

TMS # 10176 - VA Privacy and Information Awareness and Rules of Behavior

Annually 1.0

Prevention of Workplace Harassment/No Fear Annually 2.0

TMS # 10203 - Privacy and HIPPA Training Annually .5

5.0 APPROVAL OF CONTRACTOR PERSONNEL:

SAVAHCS reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor employee or subcontractor employee who, by reason of previous unsatisfactory performance at the VA or for any other reasonable cause, is considered by the Contracting Officer to be objectionable, as long as thirty (30) days written notification of unsatisfactory performance has been provided to the contractor and the problem has not been cured in the thirty (30) day period.

6.0 KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS: The Contractor shall assign to this contract the following key personnel:

a. During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions.

b. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receiving all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

c. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

7.0 ARRANGEMENT FOR REPLACEMENT STAFF:

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 bear the responsibility of providing replacement personnel to provide the scheduled services. The replacement personnel must meet the Credentialing/Privileging requirements prior to providing care to SAVAHCS patients.

8.0 QUALITY MANAGEMENT AND ADHERENCE TO POLICIES:

The contractor shall insure that contract technologists and physicians participate in continuous quality improvement programs in the organization as described in VHA Handbooks and policies below, including any subsequent updates during the period of performance. In addition, the services to be performed by the contractor will be done in accordance with VA policies and procedures, Joint Commission, federal and state laws, and the regulations of the medical staff by laws of the VA facility. This includes but is not limited to outcome measurements, access and levels of care, patient satisfaction, reporting of adverse events, and patient records. This data will be provided to the COR on a quarterly basis.

a. VA Directive 1663, “Health Care Resources Contracting – Buying” https://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

b. VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

c. VHA Directive 2006-041: “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

d. VHA Handbook 1100.17 National Practitioner Data Bank Reports http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

e. VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards -http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

f. VHA Handbook 1100.19: Credentialing and Privileging -http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

g. VHA Handbook 1907.01: Health Information Management and Health Records:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

h. Freedom of Information Act (5 U.S.C. 552) as amended:

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

i. Privacy Act of 1974 5 U.S.C. § 552a https://www.justice.gov/opcl/privacy-act-1974

j. VA Handbook 0730, “Security and Law Enforcement”

k. VA Handbook 6500.6 “Contract Security” https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2

l. VA Handbook 5011/12: Hours of Duty and Leave http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=338&FType=2

m. The professional standards of the Joint Commission (TJC) http://www.jointcommission.org/standards_information/hap_requirements.aspx

9.0 QUALITY ASSURANCE:

a. The contractor shall maintain a Quality Assurance (QA) program under this contract and provide tracked and trended data to the Surgical Care Line’s COR or designated POC, SAVAHCS, on a quarterly basis. This information will be shared with the Executive Committee of the Medical Staff (ECMS) when renewing the contract.

b. Complications incurred during the administration of this contract will be reported within 24 hours of discovery to the Surgical Care Line’s COR or designated POC. The contractor will provide SAVAHCS with a complete copy of the medical records should a complication or an adverse event occur.

c. It is anticipated that contracted services will provide the same level of oversight of quality and patient safety that SAVAHCS would provide if we were providing the service. This will be in compliance with quality of patient care contracts document that reviews Joint Commission standard and how SAVAHCS structures the contract to ensure compliance with the standard and our responsibility to ensure appropriate care.

10.0 PERFORMANCE MONITORING: The contractor will be monitored through a variety of mechanisms, including but not limited to:

a. QA monitors to assess the quality of care provided by the contractor.

b. Review of medical record documentation to ensure maintenance of patient privacy. They are not able to remove patient data from the facility.

c. The Contractor shall meet Joint Commission standards, as applicable. These performance standards may change during the course of the contract. Any new or revised quality/performance criteria or standards will be provided to the contractor before their implementation date and renegotiated into the contract as necessary. Attachment 1 contains the Performance Metrics that will be used to monitor the contractor.

d. Monitoring of contractor’s time shall be demonstrated through sign-in/ sign-out sheets. The contractor shall be required to sign an attendance log upon reporting to work and departing from work. The Contracting Officer’s Representative (COR) is designed to be the Surgical Care Line’s Administrative Officer. The COR shall be SAVAHCS’s official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

11.0 EMPLOYMENT & LIABILITY:

The contractor shall be responsible for protecting the personnel furnishing services under this contract.

To carry out this responsibility, the contractor shall provide the following for these personnel who include worker’s compensation, professional liability insurance, health examinations, income tax withholding and social security payments. The parties agree that Contractor personnel without formal VA appointments shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

11.1 Tort Liability: The Federal Tort Claims Act does not cover Contractors or Contractor’s staff.

When a Contractor or a member of their staff has been identified as a provider in a tort claim, The Contractor is responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s staff) action or non-action is the responsibility of The Contractor and/or insurance carrier.

12.0 AUTOMATED DATA PROCESSING (ADP) SECURITY:

If it becomes necessary, all contractor personnel accessing the Veterans Health Information and Technology architecture system will be required to sign and abide by all VA security policies and applicable confidentiality statues, 38 U.S.C., 5701, 7332, and the privacy act, 5U.S.C. 552a, as well as background check.

13.0 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

In accordance with VA Handbook 6500.6 Contract Security, VA Handbook 0710 VA Personnel Suitability and Security Program, and VA Directive 0710, the Department of Veterans Affairs has implemented procedures to obtain background security investigations for all contracted personnel. All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center. This requirement is applicable to all subcontractor personnel requiring the same access.

14.0 SECURITY REQUIREMENTS FOR CONTRACTOR EMPLOYEES:

The contractor shall comply with the requirements listed in the VA Handbook 6500.6 “Contract Security” and complete the forms located in Section D “Attachments” The contractor is also applicable to Contract Security Language Requirement for Liquidated Damages (See Section D).

15.0 COMPLIANCE WITH HIPAA:

Department of Health and Human Services (DHHS), as mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 45 CFR parts 160 &164, subparts A, C, E; use and disclosure of protected health information requires the Government to enter into a Business Associate Agreement (BAA) with contractors who need access to protected health information and who do not meet any of the HIPAA exceptions.

This requirement does does not meet the following exception and does does not, require a BAA

Health Care provider for treatment Health plan sponsor that provides health insurance benefits or coverage for the group health Health plan that is a public benefits program, such as Medicare or Social Security Health plan or health care provider for payment purposes Organization whose access to protected health information would be incidental (e.g. janitorial, postal, electrician, etc.)

Organization Health Care Arrangement (OHCA) relating to joint health care activities of the OHCA A person or entity for research purposes; other {explain}

16.0 SAVAHCS RESPONSIBILITIES:

The COR or designee is responsible for scheduling and coordinating with the contractor, and resolution of any operational and administrative issues. The COR will also conduct as necessary any post award discussion to review and resolve administrative issues and identify areas of concern for contract clarification. The COR is also the POC for the contractor to route issues and discussions through.

Request for service will be issued via email, telephonic, or any other medium acceptable to both parties for requesting services. Any issues that rise above routine or become disputed must be forwarded to the CO.

SAVAHCS is responsible for scheduling and coordinating with the contractor to establish a monitoring and evaluating procedure. Monitoring procedures will be established to ensure contractor compliance with established requirements. The COR will be responsible for global monitoring of contract compliance, and reporting any noncompliance as evidenced by the established monitoring procedures.

Any serious incident of noncompliance or habitual unresolved situations as evidenced by the monitoring procedures shall be reported in writing to the CO for determination and resolution.

17.0 WORK HOURS:

a. The services covered by this contract shall be furnished by the contractor as defined herein. The contractor will not be required, except in case of emergency, to furnish such services during off-duty hours as described below.

b. The following terms have the following meanings:

(1) Work hours: Monday through Friday, 7:00 a.m. - 6:00 p.m.

(2) On call hours:

Monday -Thursday 6:01p.m.-6:59 a.m.

Friday 6:01p.m.-Monday 6:59a.m.

All Federal Holidays

(3) National Holidays: The 11 holidays observed by the Federal Government are:

New Year’s Day Martin Luther King’s Birthday Presidents Day Memorial Day Juneteenth Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Christmas

Attachment 1 Service Delivery Summary

Task Performance

Measures

Acceptable Quality Level

Method of Surveillance

Authorization for Service PWS Paragraph: 3.0

Pre-approval 100%

Observation and random inspection (auditing) of daily surgical reports by

COR

The contractor must coordinate with facility for scheduled surgical procedures within allotted time frame.

PWS Paragraph: 3.0

Within 24 hours of receiving referral

100% Observation and

Auditing.

Complications incurred during the administration of this contract will be reported.

PWS Paragraph: 2.1, 3.0, 4.0,

8.0 and 9.0

Within 24 hours of discovery to the

Surgical Care Line or designated POC

100%

Observation and random inspection

(auditing) of Quality Assurance

Survey/Checklist (e.g.

read/interpret accuracy, technical problems, equipment problems) – completed by

Neurosurgery staff and reported to COR

The contractor will complete all administrative tasks, documentation of patient care and required medical transcription and signature.

PWS Paragraph: 3.0, 10.0, &

16.0

Within 24 hours of procedures

100 %

Observation and random inspection

(auditing) of Quality Assurance

Survey/Checklist (e.g.

read/interpret accuracy, technical problems, equipment problems) – completed by

Neurosurgery staff and reported to COR

Task Performance

Measures

Acceptable Quality Level

Method of Surveillance

Contractor shall maintain a Quality Assurance program under this contract and provide tracked and trended data to the Surgical Care Line or designated POC, on a quarterly basis PWS Paragraph: 2.1, 9.0 & 10.0

Quarterly Review 100 %

Observation and random inspection

(auditing) of Quality Assurance

Survey/Checklist (e.g.

read/interpret accuracy, technical problems, equipment problems) – completed by

Neurosurgery staff and reported to COR

Contracted IONMS shall be licensed in the state of Arizona.

Qualifications of personnel shall be subject for review by SAVAHCS. Personnel assigned by the contractor to perform services covered by this contract shall meet all professional qualifications and be reviewable by the

Department of Veterans Affairs.

PWS Paragraph: 2.1, 2.9, 4.0, & 6.0

At all times 100 %

At the time of contract award and any time a new contracted employee starts.

Contractor is to maintain the confidentiality of patient records in accordance with the Privacy Act, Title 5, U.S.C. 552a, Title 38 U.S.C. 5701, 5705, 7362; and the Health Insurance Portability and Accountability Act (HIPAA) under Public Law

104-191 PWS Paragraph: 8.0, 12.0, &

13.0, & 14.0

Monthly 100 % Observation and random inspection (auditing)