N62645-16-T-0002_0002.docx

DOCX document 83 KB Posted

Attached to
Intraoperative Monitoring, Naval Medical Center Portsmouth
Solicitation number
N62645-16-T-0002
Issued by

About this file

Amendment 02

View the file

Other files

File Type Posted
Revised_Schedule.docx DOCX document
N62645-16-T-0002_0001.docx DOCX document
9_-_N62645-16-T-0002.docx DOCX document
9_-_RFQ_Attachments.docx DOCX document
9_-_RFQ_Attachment_8_-_Medical_Device_Risk_Assessment.pdf PDF
9_-_RFQ_Attachment_9_-_MDRA_Instructions.pdf PDF

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

N62645-16-T-0002

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00.

To:

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.Each subCLIN is billable at a per procedure rate depending on the procedure length. Procedure length is defined as the start time of the procedure to the completion time of the procedure. Procedure length will not be extended to include equipment set-up/removal time, wait time, equipment check-in time, etc.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00..

CLIN 1002

This CLIN has been renumbered to CLIN 1001.

The CLIN extended description has changed from:

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00.

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.Each subCLIN is billable at a per procedure rate depending on the procedure length. Procedure length is defined as the start time of the procedure to the completion time of the procedure. Procedure length will not be extended to include equipment set-up/removal time, wait time, equipment check-in time, etc.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00..

SUBCLIN 1002AA

This SUBCLIN has been renumbered to SUBCLIN 1001AA.

SUBCLIN 1002AB

This SUBCLIN has been renumbered to SUBCLIN 1001AB.

SUBCLIN 1002AC

This SUBCLIN has been renumbered to SUBCLIN 1001AC.

SUBCLIN 1002AD

This SUBCLIN has been renumbered to SUBCLIN 1001AD.

CLIN 2001

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00.

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.Each subCLIN is billable at a per procedure rate depending on the procedure length. Procedure length is defined as the start time of the procedure to the completion time of the procedure. Procedure length will not be extended to include equipment set-up/removal time, wait time, equipment check-in time, etc.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00..

CLIN 3001

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00.

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.Each subCLIN is billable at a per procedure rate depending on the procedure length. Procedure length is defined as the start time of the procedure to the completion time of the procedure. Procedure length will not be extended to include equipment set-up/removal time, wait time, equipment check-in time, etc.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00..

CLIN 4001

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00.

The contractor shall provide intraoperative monitoring services in support of the Naval Medical Center Portsmouth, VA on behalf of the Government in accordance with the terms and conditions and the performance work statement contained in this contract.This is an indefinite delivery requirement. Each subCLIN includes an estimated number of procedures/occurrences. The quantities listed in the subCLINs are based on historical data and projected need. The contractor shall only be paid for services and quantities provided.Each subCLIN is billable at a per procedure rate depending on the procedure length. Procedure length is defined as the start time of the procedure to the completion time of the procedure. Procedure length will not be extended to include equipment set-up/removal time, wait time, equipment check-in time, etc.The minimum contract value for all orders issued against this contract shall not be less than $25,000.00. The maximum contract value for all orders issued against this contract shall not exceed $700,000.00..

The following have been added by full text:

CONTINUATION OF BLOCK 14

The purpose of this amendment is as follows:

1. To reopen the solicitation and extend the quote due date to 30 June 2016 at 1:00 PM.

2. To revise the PWS language regarding the storage of equipment on-site at the MTF, see Section 2.2.2.1.

3. To clarify the pricing structure. Each procedure is billable at a specified rate depending on the length of the procedure. The Schedule has been revised to indicate that procedure length is defined as the start time of the procedure to the completion time of the procedure. Procedure length will not be extended to include equipment set-up/removal time, wait time, equipment check-in time, etc. The cost for performing these tasks, as well as meeting all requirements outlined in the contract, should be included in the per procedure rate.

4. To correct the numbering for the first option period CLIN and all corresponding SLINs from 1002 to 1001.

Existing quoters shall respond by acknowledging the amendment as noted in Block 11 on the SF 30 and submitting a revised price quote, if necessary. Revised price quotes shall be submitted using the revised Schedule posted with the first amendment.

The following have been modified:

PERFORMANCE WORK STATEMENT

Intraoperative Monitoring Services Naval Medical Center Portsmouth, VA

SECTION C

SECTION 1 – SCOPE

1.1. BACKGROUND

The Contractor shall provide nonpersonal intraoperative monitoring services for Naval Medical Center Portsmouth, VA (hereafter referred to as “NMCP” and/or “MTF”) including the following modalities: somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), electromyography (EMG), electroencephalography (EEG), cortical mapping, brainstem auditory evoked response (BAER), brain stem recordings, etc. Note this is not an exhaustive list meant to limit the type of service provided. This list is provided for informational purposes only. This Contract is a nonpersonal health care services contract, under which the Contractor is an independent contractor.

The mission of Navy Medicine includes providing superior state of the art healthcare. To meet this mission, NMCP requires recurrent intraoperative monitoring of patients undergoing surgery.

1.2. SCOPE

The Contractor shall provide intraoperative monitoring services for the Main Operating Room (MOR) located at 620 John Paul Jones Circle, Portsmouth, VA 23708. The current requirement is for orthopedic procedures only; however, additional procedures may be added in the future.

SECTION 2 - DUTIES

2.1. GENERAL DUTIES

Contract employees shall perform a full range of duties consistent with their profession, education, training, experience, and assigned position. General duties that apply to all contract employees are outlined below:

2.1.1.

Function with an awareness and application of safety procedures.

2.1.2.

Exercise awareness and sensitivity to patient/significant others' rights, as identified within the institution.

2.1.3.

Complete in-service training to clinic staff members as requested.

2.2. SPECIFIC DUTIES FOR PROVIDING INTRAOPERATIVE MONITORING SERVICES

2.2.1.

The Contractor shall provide real time or live intraoperative monitoring services on an as needed basis. Remote interpretation is allowable; however, additional information technology requirements apply, see Section 12. The per procedure rates identifed in the Schedule are inclusive of all remote monitoring/information technology requirements. Services required include SSEP, MEP, EMG, EEG, cortical mapping, BAER, brain stem recordings, etc. The Contractor shall provide service in operating rooms (ORs). Work shall be performed in a medical setting. Long periods of standing may be required.

2.2.1.1.

Service is required on a case by case basis for scheduled procedures. Procedures are scheduled during the hours of 0650 and1800 Monday through Friday (normal operating hours), exclusive of Federal holidays. The Contractor shall provide service until the end of each procedure, regardless of the time, and shall recognize that there may be instances where procedure will not finish until after 1900 hours. The Government will provide notification to the Contractor when a procedure is scheduled. The Contractor shall recognize that the schedule provided may change. The Contractor shall be responsible for providing a toll-free number where requests for services can be communicated to a live person with a confirmation number communicated to the Government.

2.2.1.2.

Service for emergency procedures shall be provided at any time Monday through Sunday, including after hours, weekends and Federal holidays. When emergency procedures are scheduled, the Contractor shall be required to report to the MTF no later than two and a half (2.5) hours after receipt of notification. The Contractor shall be responsible for providing a toll-free number where requests for services can be communicated to a live person with a confirmation number communicated to the Government.

2.2.1.3.

The Contractor shall be prepared to provide service on up to two (2) procedures at the same time.

2.2.1.4.

Due to the nature of the requirement, services may be cancelled or rescheduled at any time prior to the procedure, including the day of the procedure after the Contractor arrives on-site at the MTF. The Government will not reimburse the Contractor for any fees relating to the cancellation or rescheduling of a procedure.

2.2.2.

The Contractor shall furnish, set up/prepare, operate, troubleshoot, maintain the cleanliness, and perform inspection and maintenance of the intraoperative neurophysiologic monitoring system and supplies in accordance with the manufacturer’s guidelines. The Contractor shall provide evidence of required inspection/maintenance as requested by the Government.

2.2.2.1.

The Contractor shall report to the MTF approximately one (1) hour prior to the start of each procedure to have their equipment undergo a biomedical check-in upon entry to the MTF, to be coordinated with the Contracting Officer’s Representative (COR), contact information to be provided upon award. The Contractor shall be responsible for transporting the intraoperative monitoring system and all required supplies to the MTF each time service is required. The Government will provide limited storage space for Contractor use. The entire system(s) cannot be stored on-site.

2.2.2.2.

The Contractor shall demonstrate detailed technical knowledge and troubleshooting ability for the intraoperative monitoring system.

2.2.3.

The Contractor shall be present for the positioning of the patient in the operating room (OR), attach electrodes, monitor complex nerve impulses, and provide verbal notification to the surgeon(s), anesthesiologist and other members of the surgical team regarding any danger to the patient nerve pathways during a surgical procedure. The Contractor shall be responsible for multiple types of recordings and measurement of the electrical activity of the central and/or peripheral nervous system.

2.2.3.1.

If remote interpretation is provided, the contract employee performing the interpretation shall be available via telephone to communicate with the surgeon(s), anesthesiologist and other members of the surgical team during the surgery.

2.2.4.

The Contractor shall assist the surgical team in explaining intraoperative monitoring to the patient and their escort, if applicable, pre-operatively by answering any technical questions concerning the equipment and monitoring process.

2.2.5.

The Contractor shall provide a post-surgical outcome report the day of the surgery prior to leaving the MTF.

2.2.6.

As requested, the Contractor shall provide informal education to staff members regarding general intraoperative monitoring concepts.

2.2.7.

Data on the procedures completed in the past two years is provided for historic purposes only, see Attachment 2. The actual number/type/length of procedures may vary.

2.3. EQUIPMENT AND SUPPLIES

2.3.1.

The Contractor shall furnish all equipment and supplies necessary to operate the intraoperative monitoring system and provide the services described herein.

2.3.1.1 The Contractor shall provide an intraoperative monitoring system capable of providing the services described herein.

2.3.1.2 The Contractor shall be responsible for supplying all necessary supplies to coordinate with the specific brand of intraoperative monitoring system. The following represents an estimated list of the supplies required and shall be used as reference information only: NIM EMG endotracheal tubes, APS electrodes, stim bur, probes, etc. It is the responsibility of the Contractor to ensure that all supplies needed to provide service on both a scheduled or emergent basis are available at all times.

SECTION 3 – HOURS OF OPERATION

3. 1.

Hours of operation are as described in Paragraphs 2.2.1.1. and 2.2.1.2.

3. 2.

All closings for severe weather or other emergency shall be at the sole discretion of the government. The Contractor shall maintain the required service schedule unless the COR or Surgical Staff Nurse notifies the Contractor that weather conditions or an emergency authorizes a closing. The Contractor will receive guidance from the COR or the Surgical Staff Nurse of the MTF protocol for closings.

SECTION 4 – DELIVERABLES

4.1. Quality Control Program (See Section 9)

4.2. Occupational Health Requirements (See Paragraph 10.2)

SECTION 5 – PERFORMANCE

5.1. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) MATRIX

5.1.1.

Deliverable or Service Requirement
Measurement/Metric
Performance Standard
Acceptable Quality Level (AQL)
Method of Surveillance
PWS Section 2 & 8
Technical Performance
Equipment/Supplies: Provide, set-up and operate all required intraoperative neurophysiologic monitoring system(s) and supplies need to perform services as described in the PWS, and provide troubleshooting, cleanliness, and inspection/maintenance of equipment in accordance with the manufacturer’s guidelines.
100%
Customer complaints, direct observation on a periodic basis and review of Contractor’s records, as requested by the Government
PWS Section 2
Technical Performance
Outcomes: The Contractor shall provide accurate detection of nerves leading to favorable patient outcomes. The Contractor shall provide clear communication/feedback to the surgeon during each procedure.
100%
100% inspection
PWS Section 2 & 3
Timeliness
Coverage for Scheduled and Emergency Procedures: Provide staff for procedures as scheduled and on an emergency basis within the timeframes indicated in the PWS.
100%
100% inspection
PWS Section 2
Satisfaction
Customer Feedback: COR and end users satisfied with Contractor’s overall performance.
No more than one (1) substantiated negative survey or complaint per year
User surveys or customer complaints

SECTION 6 - QUALIFICATIONS

6.1. GENERAL QUALIFICATIONS THAT APPLY TO ALL CONTRACTORS

The Contractor shall provide personnel having certain minimum levels of training and experience. This section is in no way intended to dictate a staffing plan to the Contractor for the performance of the services described herein. The services require that contract employees possess the following minimum qualifications to meet contract requirements.

6.2.

Contract employees shall maintain current certification in American Heart Association Basic Life Support (BLS), American Heart Association Healthcare Provider Course, American Red Cross CPR (Cardio Pulmonary Resuscitation), or equivalent. Training shall be the responsibility of the Contractor and is at no cost to the government. Contract employees, not in possession of current certification, must acquire certification prior to initiating contract performance. Web based classes do not meet these standards. A copy of the BCLS instruction may be obtained from the World Wide Web at: http://www.med.navy.mil/directives/ExternalDirectives/1500.15E%20CH-1.pdf.

6.3.

Be a U.S. Citizen per Attachment 5.

6.4.

Contract employees shall be current with and have completed all continuing education requirements specified by their professional licensure or certification.

6.5. SPECIFIC QUALIFICATIONS FOR PERSONNEL PROVIDING INTRAOPERATIVE MONITORING SERVICES

6.5.1. NEUROLOGIST

6.5.1.1.

Possess a Doctorate Degree in Medicine from an accredited college approved by the Liaison Committee on Medical Education and Hospitals of the American Medical Association, a Doctorate degree in Osteopathy from a college accredited by the American Osteopathic Association, or permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG).

6.5.1.2.

Possess Board Certification in Neurology by the American Board of Psychiatry and Neurology.

6.5.1.3.

Possess and maintain a current, valid, unrestricted license to practice as a neurologist from a U.S. State, territory, or district.

6.5.1.4.

Possess a minimum of one (1) year of experience within the preceding three (3) years as a full-time neurologist interpreting intraoperative monitoring.

6.5.2. INTRAOPERATIVE MONITORING TECHNICIAN

6.5.2.1.

Technicians shall possess current certification by the American Board of Registration of Electroencephalographic and Evoked Potential Technologists (ABRET) to provide neurophysiologic intraoperative monitoring (CNIM) or current certification by the American Board of Neurophysiologic Monitoring (ABNM).

6.5.2.2.

Technicians shall be trained to perform the technical services in accordance with the standards of care applicable to such services, including those established by the American Society of Electroneurodiagnostic Technologists (ASET) and/or the American Society of Neurophysiological Monitoring (ASNM). As requested, the Contractor shall provide evidence of technician’s training and procedure experience prior to performance of services.

6.6. SPECIFIC KNOWLEDGE FOR PERSONNEL PROVIDING INTRAOPERATIVE MONITORING SERVICES

The Contractor shall possess the following knowledge and, skills, and abilities:

6.6.1.

Knowledge of scientific rationale in coordination of the patient care.

6.6.2.

Knowledge of Universal Precautions.

6.6.3.

Knowledge of safety and environment of care procedures.

6.6.4.

Knowledge and expertise in the following areas of service: somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), electromyography (EMG), electroencephalography (EEG), cortical mapping, brainstem auditory evoked response (BAER), brain stem recordings, etc.

6.6.5.

Knowledge of developments in the field of Intraoperative Neurophysiologic Monitoring and Evoked Potentials.

6.6.6.

Knowledge of the affects of anesthesia and of various artifacts such as electrical interference from operating room equipment, etc., in order to be able to assess their effects on the data collected during the surgical procedure.

6.6.7.

Knowledge of potential morbidity caused by the monitoring process itself, quality control systems and procedures for preventive maintenance and performance testing and calibration of equipment and recognize when problems are beyond scope of expertise and must be referred to others.

SECTION 7 – CREDENTIALING REQUIREMENTS

7.1. Following contract award, the Contractor shall submit to the Medical Staff Services Office, via the COR, a completed Credentials Record (CR) for each required contract employee. The CR, which will be maintained at the MTF, contains specific information with regard to qualifying degrees and licenses, past professional experience and performance, education and training, health status, and competency as identified in Enclosure 6 of BUMEDINST 6010.30 of 27 March 2015 and subsequent revision. CRs for contract employees who do not currently have a CR (previously referred to as an Individual Credentials File or ICF) on file at the facility shall be submitted at least 30 days prior to commencement of services. For those contract employees who currently have a CR on file, an updated Personal and Professional Information Sheet (PPIS) for Privileged Providers, with notation that a complete up-to-date CR is on file, shall be submitted no less than 15 days prior to commencement of services. Prior to contract employees providing services, the COR will verify the compliance of each employee with the qualification requirements appropriate to their employment category. The COR shall inform the Contractor of compliance of the qualification package or any discrepancies contained therein.

7.2.Upon receipt of a complete CR, the COR will forward it to the Medical Staff Services Office for approval and credentialing of the contract employee. The Medical Staff Services Office will ensure the CR is complete in accordance with BUMEDINST 6010.30 of 27 March 2015 and subsequent revisions. The Contractor shall not assign an individual to work at the MTF until their CR has been approved and shall discontinue the service of an individual who fails to maintain compliance with qualification and credentialing requirements.

7.2.1.BUMEDINST 6010.30 is available at http://www.med.navy.mil/directives/ExternalDirectives/6010.30.pdf.

7.3. Unless otherwise specified, the Government reserves the right to transfer to the gaining Contractor the credentials of a contractor’s employee who has been granted delineated clinical privileges on a predecessor contract/task order without a new or additional credentialing action. This extension may only occur: a) within the same command; b) when there is no increased clinical competency requirement of the contractor’s employee; c) when there is no significant change in the scope of clinical practice of the contractor’s employee; d) when there is no gap in performance between the contracts; and e) when the contractor’s employee has had acceptable performance evaluations.

7.4. Notwithstanding licensure and certification requirements given in Section 6, each contract employee is responsible for complying with all applicable licensure and certification regulations.

7.5. The Contractor shall continuously maintain a current list of all individuals who have been privileged, credentialed, or approved for service under the contract, including reportables such as, but not limited to: certifications (BLS, ACLS, PALS, etc.), licenses and/or certification, etc. The Contractor shall provide a copy of the updated list to the COR not later than the 3rd business day of each month, or more often as needed to keep the information current.

7.6.

The Contractor shall maintain a complete credential file for each employee during the life of this Contract. It is emphasized that the file and the documents therein shall be kept current and shall be made available for Government inspection upon request.

7.7.

The Contractor shall inform the COR of any terminations of employment within 24 hours of the action.

7.8.

Permanent revocation of clinical privileges and permanent adverse administrative actions due to professional misconduct against licensed or certified practitioners shall be reported to the appropriate professional licensure clearinghouse and/or to the licensing authorities of the state in which the services are performed in compliance with SECNAVINST 6401.2. In addition, contract employees are advised that the Department of Defense participates in the national reporting system established under Part B of the Health Care Quality Improvement Act of 1986, Public Law 99660. Reports, naming individual practitioners, shall be submitted to the National Data Bank in accordance with this Act.

7.9.

The MTF Commander will grant clinical privileges to the contract employees during their employment by the Contractor in performance of this contract. If a provider’s employment with the Contractor ends for any reason, all clinical privileges and medical staff appointments shall be terminated without recourse to the fair hearing and appeals procedures specified by the medical staff bylaws and BUMEDINST 6320.67A.

7.10.

The Neurologist(s) providing services under this Contract must have privileges granted by NMCP.

7.11. The MTF will not credential more than seven (7) contract employees for this requirement.

SECTION 8 - GOVERNMENT AND CONTRACTOR FURNISHED ITEMS.

8.1. GOVERNMENT FURNISHED ITEMS

8.1.1.

The Government will provide, without cost, the facilities, badges and maintenance services, with the exception of intraoperative neurophysiologic monitoring system and supply maintenance, required to perform the duties of this Contract. Government-furnished property shall only be used in the performance of this Contract.

8.1.2.

A Common Access Card (CAC) will only be issued to contract employees who may require access to a Government computer. To gain access to the Government installation, the use of the RapidGate system is suggested. Commander, Navy Installations Command (CNIC), has established the Navy Commercial Access Control System (NCACS), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter Navy installations and facilities. Vendors visiting Naval Medical Center Portsmouth (NMCP) may obtain daily passes directly from Naval Station Norfolk (NSN) Pass and ID office, located at NSN (Bldg CD-9), 9040 Hampton Blvd, Norfolk, Virginia, 23505, by submitting identification credentials for verification and undergoing a criminal screening/ background check. Alternatively, if the vendor so chooses, it may voluntarily elect to obtain long-term credentials through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own cost through one of the designated independent contractor NCACS service providers. Credentials will be issued every five years and access privileges will be reviewed / renewed on an annual basis. The costs incurred to obtain Navy installation access of any kind are not reimbursable, and the price(s) paid for obtaining long-term NCACS credentials will not be approved as a direct cost of this contract. Further information regarding NCACS can be found at http://cnic.navy.mil/CNIC_HQ_Site/index.htm.

8.1.2.1.

Contract employees background investigations must be initiated seven (7) calendar days after contract award and an advance fingerprint and NACLC results received by the MTF prior to a Common Access Card (CAC) being issued to contract employees.

8.1.3.

The Government will provide base access cards for all contract employees to be used in accordance with base and MTF policy during the initial check-in procedure with the COR. Contract employees shall comply with the military base policies and instructions for gaining access to the military base. The identification badge shall be worn during performance of work and anytime contract employees are on the premises. The Contractor shall ensure that each employee’s I.D. badge is returned to the COR when contract employees are no longer providing services under this Contract due to termination/expiration of the contract.

8.2. CONTRACTOR FURNISHED ITEMS

8.2.1. INSURANCE

This is a non-personal service Contract, so the Contractor is required to have their own insurance.

8.2.1.1. AUTOMOBILE LIABILITY INSURANCE.

Before commencing work under this Contract, the Contractor shall certify to the Contracting Officer in writing that the required automobile insurance has been obtained. The following insurance as referenced in Federal Acquisition Regulations (FAR) Clause 28.307, is the minimum insurance required:

Automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing this Contract. Policies covering automobiles operated in the United States shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

8.2.1.2. WORKERS’ COMPENSATION AND EMPLOYER’S LIABILITY

The Contractor shall comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with the Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 shall be required, except in states with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

8.2.1.3. MEDICAL LIABILITY

The Contractor shall comply with applicable requirements of the FAR Clause 52.2377, Indemnification and Medical Liability Insurance (JAN 1997).

8.2.1.3.1.

The Contractor shall complete the Malpractice Insurance Certification Form, Attachment 6, as part of the Quote and shall provide an updated form to the COR upon request.

8.2.2. SERVICES

8.2.2.1.

During the term of this Contract, contract employees shall provide, on behalf of the Government, intraoperative monitoring services to active duty military personnel, their dependents, eligible Navy civilian employees, and other eligible beneficiaries, in accordance with the terms and conditions of the contract.

8.2.3. EQUIPMENT

8.2.3.1.

The Contractor shall acquire, maintain and provide in good working order the dedicated equipment, internet access (if applicable), technology, and software required to provide intraoperative monitoring services. The costs of repair and/or replacement of such equipment, technology or software will be the sole responsibility of the Contractor. The Contractor agrees to abide by the MTF’s policies and procedures regarding the maintenance, use and safety of any clinical equipment utilized on-site at the MTF. The Contractor shall ensure full maintenance of all equipment used in conjunction of the requirements of this Contract. All maintenance records are to be written and available for review by the Government with a minimum five (5) calendar day advance notice.

8.2.4. SUPPLIES

8.2.4.1.

The Contractor agrees to provide all supplies required to provide intraoperative monitoring services. The Contractor’s price should be inclusive of all cost to include any required, labor, transportation and consumable items/supplies. The Government will not provide any consumable items/supplies that are required for the operation of Contractor’s equipment or provision of services described herein.

SECTION 9 – QUALITY CONTROL

9.1. QUALITY OF SERVICE

This is a nonpersonal services Contract that supports the MTF mission to oversee and coordinate the delivery of economical and effective medical, dental and other health care services. The intraoperative monitoring services required by this Contract support the provision of patient care in the medical treatment facilities within the Area of Responsibility (AOR) and ensure services are available to beneficiaries. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

9.1.1.

The Contractor shall comply with applicable provisions of the law, rules and regulations of all governmental authorities, including but not limited to, the regulations and standards of the MTF. The Contractor shall adhere to and comply with all Department of Navy (DON), Bureau of Medicine and Surgery (BUMED) and MTF Instructions and notices which may be in effect during the term of this Contract.

9.1.2.

To achieve the MTF mission, the Contractor shall establish, submit for government approval and implement a Quality Control Plan (QCP) which is consistent with the MTF Quality Control Program. The Contractor shall also actively participate in the established medical Quality Improvement (QI) Plan of the MTF. Current copies of this Contract, the Contractor’s QCP, and the MTF’s QI plan shall be maintained on-site for ready reference by the Contractor during the term of this Contract. Contract employees shall read, be familiar with, and implement this Contract, including the Contractor’s technical approach, QCP, medical QI Plan, and any revisions.

9.1.3.

After contract award, but not later than commencement of services, the Contractor shall submit a Quality Control Plan to the COR and the Contracting Officer for review. The Contractor’s QCP shall be consistent with Joint Commission standards and the MTF Quality Control Program. The QCP shall, at a minimum, include (a) a plan for providing services by appropriately qualified personnel that includes a specific methodology for doing so; (b) a plan to ensure maintenance and enforcement of Standards as specified in Section 11; and (c) a plan for a patient relations program that is compliant with the MTF's patient relations protocols and which includes a notification process for all patient compliments and complaints.

9.1.4.

Upon receipt of the Contractor's QCP, the MTF will review and provide comments to the Contractor. If the MTF finds deficiencies in any portion of the proposed QCP, the Contractor shall have five (5) business days to correct the deficiencies. The MTF COR will provide final approval of the QCP.

9.2. INDEPENDENT CONTRACTOR

9.2.1.

The services provided by the Contractor are provided in the capacity of an independent contractor. The government will evaluate the quality of services for purposes of contract inspection and acceptance. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Contractor shall recognize that the Commanding Officer maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and U.S. Navy Regulations.

9.3. MODIFICATIONS

9.3.1.

The Contracting Officer will designate and authorize an individual to act as the Contracting Officer's Representative (COR). Any such representative appointed will be specifically designated by letter from the Contracting Officer. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contractual modification or adjustment. Changes in the scope of work can only be made by modification properly executed by the Contracting Officer. All observations made by persons other than the Contracting Officer or the COR are strictly advisory and shall not influence the Contractor's operations except for administrative requirements and responsibilities specified herein.

SECTION 10 - START OF SERVICES

10.1. BACKGROUND INVESTIGATION

10.1.1.

Contract employees shall report to the COR on the first day of contract performance. The COR or technical assistant (TA) shall provide direction for a proper check-in and any additional documentation or instructions that may be necessary for contract performance. Contract employees shall return the completed check-in sheet to the COR within ten (10) business days.

10.1.2.

Upon receipt of an adjudicated Federal background investigation or at a minimum advanced fingerprint results, the Command Trusted Agent will enter contract employees into the Contractor Verification System (CVS). Contract employees are responsible for completing the CVS application for requesting issuance of a Common Access Card (CAC).

10.1.3.

Thirty (30) calendar days prior to performance of services under this Contract, the Contractor’s Security Representative shall submit to the MTF Security Manager via the COR the necessary documents to obtain the appropriate Federal background investigation.

10.2. ADDITIONAL REQUIREMENTS

10.2.1.

The requirements are provided on the HEALTH EXAMINATION AND IMMUNIZATION/SCREENING REQUIREMENT FORM, the current version of which is available at: http://www.med.navy.mil/sites/nmlc/Public_Docs/Physical%20Exam%20and%20Immunization%20Form.pdf. This form shall be completed after award for all contract employees providing services under this Contract and provided at least thirty (30) calendar days prior to performance start date. The MTF will identify any contract employees who are not required to complete this documentation after contract award. Declinations shall only be permitted based on either contract employees religious convictions or medical contraindications (as documented by a qualified health care provider).

10.2.1.1 Except for those contract employees who decline Hepatitis B vaccine, the Hepatitis B requirements given in HEALTH EXAMINATION AND IMMUNIZATION/SCREENING REQUIREMENT FORM specify that a employee must either show a positive titer or demonstrate persistent non-response to the vaccine. A contract employee may be approved for service at the MTF prior to achieving a Hepatitis B positive titer or demonstrating a persistent non-response according to the following provisions:

10.2.1.2.

A contract employee must receive the first vaccination of his/her initial vaccination series prior to commencing service under the contract and must complete the series not later than 6 months after commencing service and, if a negative titer is obtained, must complete the second series within another 6 months; or

10.2.1.3.

A contract employee who has completed his/her initial series and obtained a negative titer must commence his/her second vaccine series prior to commencing service and must complete the second series not later than 6 months after commencing service.

10.2.1.4.

Contract employees approved according to the provisions above will be considered persistent non-responders until there is evidence to the contrary and will be counseled by a licensed practitioner regarding the implications of non-response.

10.2.1.5.

If a contract employee fails to comply with the applicable schedule above, the Contractor shall replace the employee, if so directed by the contracting officer.

10.2.1.6.

Except as noted herein, no medical tests or procedures required by the contract may be performed at the MTF. Expenses for all required tests and/or procedures shall be borne by the Contractor at no additional expense to the Government.

10.2.1.7.

Contract employees who do not show a positive antibody titer after immunization and appear to have a "non-immune" status must report varicella exposure to the COR. In accordance with CDC recommendations, such employees may be removed from patient care duties beginning on the tenth day following exposure and remain away from work for the maximum incubation period of varicella (21 days).

10.2.1.8.

Prior to reporting for service at an MTF, each contract employee shall be screened at Contractor expense for risk of exposure to tuberculosis (TB) as part of the Health Examination and Immunization/Screening Requirement Form in Section 10.2.1. If the employee is determined to have a low risk of exposure, no further screening or testing is required under this Contract. The initial screening may be waived, at the discretion of the MTF, if the Contractor provides evidence of a prior low risk assessment by a licensed physician. If the initial screening results in a determination that the employee has an increased risk of exposure to TB, the Contractor shall be responsible for ensuring that the employee receives targeted screening and testing in accordance with CDC Guidelines for Health-Care Settings and submitting timely records of subsequent screening or testing to the COR.

10.2.2.

Contract employees performing services remotely are exempt from the occupational health requirements noted herein.

10.2.3. HUMAN IMMUNODEFICIENCY VIRUS (HIV)

10.2.3.1. MANAGEMENT OF HIV POSITIVE CONTRACT EMPLOYEES

10.2.3.1.1 HIV positive contract employees will be managed in accordance with the current CDC guidelines and Section 503 of the Rehabilitation Act (29 U.S.C. Section 793) and its implementing regulations (41 CFR Part 60-741).

10.2.3.2. PREVENTION OF THE TRANSMISSION OF HIV

10.2.3.2.1.

Contract employees shall comply with the CDC’s Universal Precautions for the prevention of the transmission of HIV.

10.2.4. BLOOD-BORNE PATHOGEN ORIENTATION PROGRAM

Contract employees shall participate in the MTF’s Blood-borne Pathogen Orientation Program. The contract employee shall also participate in all required annual training and in periodic training for all procedures that have the potential for occupational exposure to blood-borne pathogens.

10.2.4.1.

All contract employees shall comply with infection control guidelines to include the proper handling, storage, and disposal of infectious wastes and the use of universal precautions to prevent the spread of infections.

10.2.5. MANAGING THE CLINICAL RISK IN THE WORK ENVIRONMENT

The work environment inherently involves risks typically associated with the performance of job duties. Contract employees may be exposed to contagious diseases, infections and flying debris, requiring the wearing of personal protection equipment such as scrub attire, gloves, masks, and eye protection.

10.2.5.1.

In the event of an exposure, the Contractor and the MTF will cooperate, in accordance with applicable MTF policy, regarding offering appropriate post-exposure testing to the affected contract employee and the MTF will use its best efforts to appropriately test the source patient and obtain the patient’s consent to disclose the test results to contract employees and the Contractor. The Contractor will be responsible for providing appropriate follow-up medical care and counseling, if applicable, and record-keeping.

10.2.5.2.

Contract employees with a bona fide medical emergency occurring while on duty, or with an on-the-job injury, will be provided stabilizing medical care according to the procedures of the MTF. The Contractor shall reimburse the government for all medical services provided unless the contract employees are otherwise entitled to government medical services.

10.2.5.3 All accidents which may arise out of or in connection with the performance of services required herein, and which result in injury, death or property damage, shall be reported to the Safety Department and the COR immediately and to the MTF QI Department within 24 hours. Verbal reports shall be followed by written reports within 24 hours. Statements of witnesses shall be included. If any claim is made by a third party against the Contractor on account of any accident which occurs in connection with the performance of this Contract, the Contractor shall promptly report the facts in writing to the Command Legal Advisor, the MTF QI Department, the Command Safety Department, and the COR.

10.3. ORIENTATION

10.3.1.

Each contract employee providing service under this Contract shall undergo an orientation. On a case-by-case basis, the government may waive orientation sessions if the contract employee is currently or has previously worked at the MTF.

10.3.1.1.

Command Orientation, provided by NMCP consists of one (1) eight (8) hour day and addresses the Joint Commission, Infection Control, Blood Bank, Command Evaluation, Hazardous Materials, TRICARE, Health Stream, Defense Medical Human Resources System Internet (DMHRSi) , Legal, Library Services, Mentorship, Red Cross, Safety Office, Police Department, Healthstream, Health Insurance Portability and Accountability Act (HIPAA), an Environment of Care walk through, etc.

10.3.1.2.

Information Systems Orientation is provided by NMCP and is approximately 16 hours. This orientation includes the Composite Health Care System (CHCS) and Armed Forces Health Longitudinal Technology Application (AHLTA).

10.3.1.3.

Unit/Clinic Orientation is provided by NMCP and/or branch clinic. It includes the specific procedures/policies in the unit/clinic where services are being provided.

10.3.1.4.

Contract employees shall complete all command required training, including but not limited to Diversity, HIPAA, Healthstream, and Navy Knowledge Online courses.

10.3.1.5.

The COR will provide a list of training times up to 30 days in advance. Orientation shall be completed within sixty (60) days of the contract employee start date.

10.3.2.

The Contractor shall not bill separately for orientation. All expenses related to orientation shall be included in the per procedure rates.

10.4. EMERGENCY PREPAREDNESS PLAN

10.4.1.

Contract employees shall…

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it. Updated .