Q--In home sleep studies

STATEMENT OF WORK C.0 SCOPE: Provide in-home unattended sleep apnea testing services (referred to as sleep study) on any patient referred by Tennessee Valley Healthcare System TVHS, in accordance with the requirements of this Statement of Work. All sleep studies shall be performed using a FDA-approved and clinically validated portable test device for sleep apnea testing and evaluation of the pressures necessary to alleviate obstruction during sleep. Services shall be provided under the authority of 38 U.S.C. 8153 and in accordance with all terms, conditions, and provisions of the resulting contract for a period including a base year and three (3) one-year option periods. C.1. Contractor Responsibilities: C.1.1. The contractor shall provide all necessary labor, materials, supplies, equipment, consultation, assistance, and expertise to perform unattended diagnostic sleep apnea studies in the homes of all patients referred by the VA. C.1.2. The Contractor shall provide sleep studies to an unlimited number of patients referred by the VA simultaneously. No limitation shall be placed on the number of veterans provided a sleep study. The VA may refer as many veterans as desired, including those patients requiring immediate testing due to medical necessity or policy. C.1.3. The Contractor shall arrange for the scheduling of routine sleep studies, estimated at 90 per month, within 5 business days of the receipt of the referral. All sleep studies shall be scheduled to be performed within 30 calendar days of initial referral from the VA. If a situation prohibits meeting these scheduling requirements, only the COTR will have the authority to modify, per patient, the scheduling requirements. The Contractor shall advise the VA of any delay by the patient in completing the sleep study. The length of time involved for a complete routine sleep study is three nights. C.1.4. Prior to scheduling the patient for an in-home sleep study, the contractor, at no additional cost to the Government, will contact the patient to provide instruction and determine whether patient (or significant other) is capable of following the instructions necessary to set-up the equipment and perform all tasks required to accomplish a successful sleep study. By the next business day, the contractor shall advise the VA of any patient deemed incapable of fulfilling the requirements. C.1.5. The Contractor shall provide a FDA-approved and clinically validated portable test device for sleep apnea testing at the residence of any VA-referred veteran. No geographic restriction shall be placed on any veteran to be tested who is enrolled at the Tennessee Valley Healthcare System TVHS. The Contractor is responsible for the equipment during transportation to and from the veteran's residence. The Contractor is responsible for all shipping charges to and from the veteran's residence. The Contractor shall provide packaging material, instruction, and documentation required for the return shipment. Neither the VAMC nor the Veteran will be charged for any damaged equipment regardless of the reason. C.1.6. Testing and requirements for in-home sleep studies shall include, but may not be limited to, the following physiological parameters: C.1.6.1 Oral/nasal airflow C.1.6.2. Apneas and hypopneas C.1.6.3 Pulse oximetry C.1.6.4. Lead detection C.1.6.5.Mouth breathing C.1.6.6. Snoring C.1.6.7. Heart rate C.1.6.8. Patient compliance C.1.7. The Contractor shall provide a questionnaire packet to the patient to record their health status information, such as patient's history, health behaviors, and lifestyle factors (sleep specific and non-sleep specific). VA will review and approve the questionnaire prior to initial use. C.1.8. The Contractor will analyze the data for each VA-referred veteran and provide the COTR with a comprehensive report within 7 business days of completion of the sleep study. C.1.8.1 Analysis of all test data shall be performed by a Respiratory Therapist or a Registered Polysomnongraphic Technologist who will forward the data for physician interpretation. C.1.8.2. A board certified/board eligible polysomnongraphy physician shall perform the interpretation of all test data. C.1.8.3. The written documentation provided for each test in the final sleep study report shall cover the three (3) nights of collected sleep data, including respiratory events, (apneas and hypopneas, A & H index), snoring intensity, blood oxygen saturation, pulse rate and respiratory effort, and shall also include patient-reported information and outcomes data. The final report will include physician interpretation, recommendations, and comments. If the study is positive for sleep apnea, the physician interpretation shall include one or more of the following factors: C.1.8.3.1. The veteran has chronic respiratory failure. C.1.8.3.2. The veteran requires the use of Continuous Positive Airway Pressure (CPAP). C.1.8.3.2. The veteran has persistent daytime somnolence. C.1.8.3.3. The veteran is asymptomatic. C.1.8.4. The final report shall be sent to the COTR or designee via a CD in WORD format which will be password protected, or in another electronic format with acceptable security measures. C.1.8.5. If a sleep study is aborted by the patient, the contractor shall notify the VAMC the next business day after study was aborted and provide reason. The contractor will be compensated for completed studies only. C.1.9. If it is determined by the Chief, Neurology Service that the interpretation of the sleep study is inadequate, a repeat sleep study will be performed at no additional cost to the VA. C.1.10. The contractor shall meet the requirements of the Privacy Act, HIPPA and HSS final rules, and all confidentiality rights of patients. C.1.11. The contractor shall have a 24-hour, 7 day/week help line for patients requiring assistance. C.1.12. The contractor will provide a monthly quality assurance report to the COT R or designee up to but not limited to: identifying patients that were unobtainable; patients that have insufficient data from the test; patients that do not wish to perform the test; patients that have moved out of state. C.2 Qualifications: C.2.1. The physicians proposed to work under this contract shall be board certified in polysomnongraphy and shall possess a full and unrestricted licensed in any State, Territory, or Commonwealth of the United States or the District of Columbia. C.2.2. Other individuals involved in conducting the sleep study shall have at least one year of specialized experience/or be a graduate of an accredited school in polysomnongraphy. Individuals shall be registered or registry-eligible in the field of sleep medicine and/or respiratory therapy. Documentation of competency to perform the duties assigned as referenced above shall be provided. C.2.3. The Contractor and all personnel assigned shall be proficient in computer reporting and documenting. C.2.4. Documentation/evidence of qualifications and evidence of JCAHO accreditation must be provided with the initial offer to be considered responsive. If during performance changes in staffing occur, they must be filed with the contracting officer and approved prior to performance. Qualifications shall be subject to review and approval by the Chief, Neurology Service. C.3 Performance: The contractor shall meet or exceed all JCAHO Hospital Standard Elements while providing the services specified, and shall perform in accordance with all terms and conditions stated herein. C.3.1. The service to be performed by the contractor will be under the direction of the Chief, Neurology Service at the Tennessee Valley Healthcare System TVHS. C.3.2. All applicable VAMC policies and procedures shall be followed by the contractor. Policies and procedures are available for review. C.4 Term Of Contract: This contract is effective for one year from date of award, plus 3 one-year options that may be exercised by the VA. The contract is subject to the availability of funds. The contractor shall perform no services after September 30 of any year until the Contracting Officer authorizes such services in writing. C.5 Medical Records: Clinical reports of VA beneficiaries created by the contractor shall be forwarded to the Tennessee Valley Healthcare System TVHS. These reports will become the property of the VA. C.6 Monitoring Procedures: C.6.1. A description of the monitoring procedures used by the VA Medical Center to ensure contract compliance will be established as follows: C.6.2. Authorization will be provided to the Contractor for scheduling of the patient and this will be annotated on the Consultation Request in the Computerized Patient Record System by a designated VA employee. C.6.3. Upon receipt of the verified report in WORD format on a CD, it will be entered as the result to the consultation request. This will permit computerized tracking that can be matched with the vendor's billing, and verified by the Chief, Neurology Service or his/her designee. C.6.4. The contractor shall submit a monthly invoice, in arrears, to the Chief, Primary Care Service, which will include the patients name, the date of examination, the fee charged. C.6.5. Any incidents of contractor noncompliance as evidenced by the above monitoring procedures will be forwarded immediately to the Contracting Officer. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical and/or professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with FAR 37.401(b). C.7 Personnel Policy: C.7.1. This is a Non-Personal Services Contract. The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide Worker's Compensation, Professional Liability Insurance, Health Examinations, Income Tax Withholdings, and Social Security Payments. The parties agree that such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor. C.7.2. Liability: Worker's Compensation and Employer's Liability. Contractors are required to comply with applicable Federal and State workers' compensation and occupationaldisease statues. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy. Employer's liability coverage of at least $1,000,000 shall be required. C.7.3. General Liability. (1) The contracting officer shall require bodily injury liability insurance coverage written on the comprehensive form policy of at least $500,000 per occurrence. C.7.4. The above referenced insurance coverage minimums are in reference to VAAR Clause, 852.23707, included in full text as an addendum to FAR 52.212-4. C.7.5. Certificate of Insurance must be received before prior to contract performance. C.8 Contract Work Days: C.8. The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required to furnish such services, except in case of an emergency on a national holiday or during non working hours as described below. C.8.1. Workdays - Monday through Friday C.8.2. Non Working Days: All Saturdays and Sundays. C.8.3. National Holidays - the ten holidays observed by the Federal government are New Years Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. C.9 Payments: Payment will be provided for completed studies only. Invoices shall be submitted monthly, in arrears, no later than the fifth day of the month following the month in which the services were provided. Payment shall be made within 30 days after receipt of a properly submitted invoice. Invoices shall include the patient's name, the dates testing was performed, the contract fee and a copy of the report. C.10.0 JCAHO STANDARD ELEMENTS: C.10 .1. Patient Rights: C.10 .1.1. All eligible veterans with assessed needs will be referred for in-home unattended sleep apnea testing through the computerized patient record system (CPRS). Contract provider(s) will initiate direct communication with the patient as clinically indicated. Care provided will respect and integrate the patient's beliefs, values and cultural influences. C.10.1.2. Protection of all patient rights is of highest priority. VAMC staff will provide all patients a copy of the Patients Rights handbook on entry to care. Patient privacy and confidentiality will be maintained at all times. The contracted personnel are required to review the Patient Rights handbook, and follow the standard of care. No patients will be subject to any research activity without his/her fully informed consent. The contractor shall abide by the VAMC Code of Ethics, which addresses marketing, admission/transfer and referral processes, and billing issues. Patient privacy and confidentiality shall be maintained at all times. All patient complaints which cannot be resolved by the contractor shall be referred to the VAMC Patient Representative. C.10.1.3. VA - The contractor and patient care services provided shall be included in VAMC data collection activities related to patient compliments, complaints and satisfaction. C.10.1.4. No eligible veteran shall be denied care for treatment which is not reimbursed by the third party insurance carrier. C.10.2. Patient Safety: C.10.2.1. Patient Safety shall be a primary focus of the contractor. Every effort shall be made by the contractor to prevent falls, and patient injury caused by acts of commission or omission in the delivery of care. Contractor shall follow all Patient Safety Standards. All events related to patient injury and other breeches of patient safety will be documented utilizing the contractor's format and reported to the COTR C.10.2.2. The VA will provide the contractor with VAMC Sentinel Event definitions in the start-up phase. C.10.2.3. The contractor shall verbally notify the VAMC COTR immediately when a Sentinel Event has occurred, which is to be followed by written notification within 3 working days. C.10.2.4. The VAMC will determine when a Root Cause Analysis (RCA) is required of the contractor. C.10.2.5. The contractor shall conduct all RCAs according to VAMC policy, and within established timeframes. C.10.2.6. Completed RCAs shall be provided to the VAMC COTR. C.10.3. Patient Assessment: All care provided shall be based on assessed patient needs. Contractor findings will be recorded and forwarded to the VA for inclusion in the patient's computerized medical record. C.10.4. Care of Patients: All care shall be provided by licensed, qualified, competent, and appropriately privileged individuals. C.10.5. Patient Education: Education provided by the contractor will be interactive with the patient, and will be aimed at disease management and prevention and quality of life. All education given will be documented in accordance with VAMC policies and procedures. C.10.6. Performance Improvement: C.10.6.1. The contractor shall have a Performance Improvement (PI) program. Monitoring for continuous compliance with Joint Commission standards through established data collection mechanisms is recommended. Aggregate and/or practitioner-specific measurement and outcome data shall be maintained. Measures related to contract compliance will be determined by the Contracting Officer's Technical Representative (COTR). High priority shall be given by the contractor to the prevention of risk for the patient. The contractor shall implement process-related internal controls to prevent risk to the veteran. C.10.6.2. The PI program will entail monitoring of clinic processes, patient outcomes and satisfaction, data analysis and collaborative design and operationalization of improvement opportunities. C.10.6.3. Contractor PI activities may be directed by the VAMC, VISN, or VHA, as well as accreditation or licensing bodies. C.10.6.4. The contractor shall abstract, compile and report PI data as requested by the VAMC. C.10.6.5. Data collection methodology, report format, and reporting deadlines will be defined by the VAMC. C.10.6.6. Examples of required PI activities include VHA Performance Measures/Clinical Practice Guidelines program, and the JCAHO ORYX or Core Measurement program. C.10.6.7. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. C.10.6.8. In all cases, the contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. C.10.7. Environment of Care: C.10.7.1. The contractor shall maintain a safe environment at all times, and follow all safety and emergency preparedness policies. Compliance with all safety management plans will be continually demonstrated. C.10.7.2. Routine and recurrent preventive maintenance inspections shall be the responsibility of the contractor. C.10.7.2.1. All significant problems identified shall be reported verbally to the COTR within 24 hours. C.10.7.2.2. A written corrective plan of action shall be submitted to the COTR within 5 working days. C.10.7.2.3. Timeframes and priorities for completion of action plan items will be mutually agreed upon by the contractor and the VAMC Safety Officer. C.10.7.2.4. An annual compliance report addressing preventive maintenance inspections, as well as Safety/Environmental/Infection Control inspections, shall be reported to the COTR. C. 10.8. Human Resources: The contract provider(s) shall be a board-certified in the modality(s) specified and the contractor will continually monitor performance. Outcomes from monitoring data, peer review and the patient compliment and complaint process will be collected and retained. The contractor shall maintain a culture that promotes self-development and learning, which is designed to maintain or enhance required competencies. Non-physician staff shall maintain current licensure or certification as required in the job description. C.10.9. Information Management: The contract provider(s) shall meet all time frames for results reporting. C.10.10. Medical Staff: The contract provider shall practice within a framework that is clinically relevant and scientifically valid. Provision of care shall be based on clinical standards of practice, and scientifically based clinical practice guidelines. C.10.11. Infection Control: C.10.10.1. Contracted patient care activities shall be integrated into the VMAC Infection Control program, and contract staff shall adhere to VAMC Infection Control policies and procedures. C.10.10.2. The VAMC Infection Control Plan shall identify for the contractor how risks will be identified, methods to be used to reduce risk, identification and reporting of community-acquired and nosocomial infections, and data collection and reporting requirements. C.10.10.3. Reports of surveillance, control, prevention and monitoring activities performed by the VAMC will be provided, on a routine basis, to the contractor.