PWS - Dialysis Services - FCC Butner.pdf

I. Background

The Federal Bureau of Prisons (BOP) was established in 1930 to provide more progressive and humane care for Federal Adults in Custody (AIC), to professionalize the prison service, and to ensure consistent and centralized administration. Today, the BOP is responsible for the custody and care of approximately 174,837 Federal offenders. The Federal prison system is a nationwide system of prisons and detention facilities for the incarceration of Adults in Custody (AIC) who have been sentenced to imprisonment for Federal crimes and the detention of individuals awaiting trial in Federal court. The defined mission of the BOP is as follows:

It is the mission of the Federal Bureau of Prisons to protect society by confining offenders in the controlled environments of prisons and community-based facilities that are safe, humane, cost-efficient, and appropriately secure, and that provide work and other self-improvement opportunities to assist offenders in becoming law-abiding citizens.

As an agency under the Executive Branch of the United States Government, the BOP receives an annual appropriation of funds to accomplish its assigned mission. The public trust demands that this annual appropriation be prudently managed. Thus, dollars spent to maintain the health of the AIC Population must reflect the agency’s best efforts to obtain cost-effective health care consistent with community standards.

The Bureau of Prisons (BOP), Field Acquisition Office (FAO), intends to make a single award to a responsible entity for the provision of Dialysis and Nephrology Services as set forth in the solicitation/contract. These services will be rendered on-site for the AIC at the Federal Correctional Complex located in Butner, NC. The FCC consists of five facilities: a Low Security Correctional Institution (LSCI), two (2) medium security Federal Correctional Institutions (FCI), a minimum-security satellite Federal Prison Camp (FPC), and a Federal Medical Center (FMC).

The FCC houses and provide inpatient and outpatient medical and Mental Health Services to AICs of multiple security levels, including high, medium, low, and minimum security.

II. Statement of Output

Performance of Dialysis and Nephrology Services are defined within this Performance Work Statement utilizing a “performance-based” approach. Thus, required services are described in terms of output rather than specific task assignments. The BOP desires to make an award to the offeror who can provide the best value, considering evaluation criteria specified in the attachments.

Output #1: Provide FMC-based Dialysis (including Hemodialysis and Peritoneal Dialysis) Services which conform to community standards and all local, state, and Federal laws and regulations applicable to the delivery of health care to members of the general public.

Output #2: Provide FMC-based diagnostic and follow-up evaluations by a Nephrologist which conform to community standards and all local, state, and Federal laws and regulations applicable to the delivery of health care to members of the general public.

Output #3: Manage medical record information in a manner which promotes continuity of care while observing restrictions on the release of information.

Output #4: Maintain open avenues of communication, facilitating the exchange of information between the contractor and the Government regarding the contract services.

Output #5 Submit properly priced invoices for services rendered.

Compliance with Contract Requirements

The Contractor’s efforts under this contract shall be monitored to ensure that the required output is achieved. The Government reserves the right to inspect and evaluate in a reasonable manner all services rendered during the performance of this contract. The Contractor shall provide the contract services in a manner consistent with the medical needs of patients and standards of quality and cost-effective patient care.

The Contractor shall maintain an active on-going quality assurance and utilization review program to include quality assurance monitoring and maintenance of equipment necessary to perform the services. This information shall be made available to the Quality Council at FCC Butner. In addition, the Contractor shall be responsible for all required infection control surveillance, monitoring, and reporting to the institution Infection Control Coordinator and Performance Improvement Council.

Specific Requirements

Output #1: Provide FCC-based Dialysis (including Hemodialysis and Peritoneal Dialysis) Services which conform to community standards and all local, state, and Federal laws and regulations applicable to the delivery of health care to members of the general public.

General. The Contractor shall provide for the complete management, staffing, and operation of the FCC 20-chair Dialysis Services Unit at the FMC. Services shall be provided on-site within the Health Services Unit of the FMC. The FMC Dialysis Services Unit shall receive patients between the hours of 6:00 am and 4:30 pm, Monday through Saturday, including Federal holidays.

The Contractor shall provide services to both acute and chronic dialysis patients, including those with communicable and infectious diseases. Hemodialysis Treatments will be provided as needed and will normally be provided three times per patient per week. Peritoneal Dialysis Treatments will also be provided as needed. Each patient will be treated according to an individualized treatment plan written by the Nephrologist.

The contractor shall develop and implement a written, individualized plan of care that specifies the services necessary to address each patient’s needs as identified by the comprehensive assessment and any changes in the patient’s condition. The plan of care must include measurable and expected outcomes and estimated timetables to achieve outcomes. Outcome goals must be consistent with current professionally accepted clinical practice standards which address, at a minimum, the dose of dialysis/volume status with consideration to blood pressure, avoiding ultrafiltration rates ≥ 13 mL/kg/hr, minimum delivered Kt/V ≥ 1.2 (URR≥65), mineral metabolism and renal bone disease markers, anemia, and vascular access.

Services shall include specialized testing to include but not be limited to transonic studies on a quarterly basis and Kinetic Clearance of the peritoneal fluid for peritoneal dialysis patients, blood transfusions as ordered by the Nephrologist, and education/training to each patient.

The contractor must develop, implement, maintain, & evaluate an effective, data-driven QAPI (quality assessment & performance improvement) program that focuses on indicators related to improved health outcomes which address, at a minimum, hemodialysis adequacy, mineral metabolism and renal bone disease, anemia management, vascular access, and fluid volume status.

The Contractor shall be responsible for the proper handling of biomedical waste and contaminated materials and shall prepare such for disposal according to policies and procedures issued by FCC Butner.

The Contractor shall be certified/accredited by the Community Health Accreditation Program (CHAP) and/or a nationally recognized healthcare accreditation agency.

The BOP reserves the right to utilize another medical facility to perform these services in an emergency situation when services cannot be provided at the FCC, e.g., facility emergency, power failure, lack of water, etc.

Staffing. The Contractor shall be responsible for determining the staffing required to operate the FCC Dialysis Services Unit. The Contractor shall provide the services of medical staff who have appropriate educational qualification, experience, licensure, and certification (where required).

When treatments are being provided, the Contractor shall ensure that at least one Registered Nurse is on-site who has received specific training in the management of patients with acute and chronic end-stage renal disease.

All Contractor staff shall have received specialty training in dialysis operations prior to assuming institution involvement.

The Contractor shall provide all credentials of medical personnel prior to their performance at the FCC, otherwise the contract medical personnel will not be allowed access to the FCC. All Contractor employees/subcontractors requiring professional licensure shall maintain active licenses issued by any state within the United States. If requested by the Contracting Officer, the Contractor shall be required to document primary source verification of the credentials for each employee/subcontractor including, as applicable, current license from the appropriate State Board of Medical Examiners and education from schools or universities.

The Contractor shall ensure that all Contractor’s health services staff shall be free of infectious diseases. Any individual performing services under this contract who subsequently develops a medical condition which might reasonably be expected to place other workers or patients at risk shall be immediately removed from activities which might reasonably be expected to place other workers or patients at risk. The Contractor shall ensure that its employees/subcontractors are in compliance with preventive, prophylactic, and follow-up procedures, as well as infection control and employee health program procedures.

All contract personnel providing services within the confines of the FCC shall have a complete background investigation conducted in accordance with BOP Program Statement 3732.01 “BOP Identifications and Background Investigation.” This background investigation will be conducted initially and recur every five (5) years for the duration of the contractor's service. Continued service is contingent upon a favorable adjudication. The background investigation includes but is not limited to a comprehensive check of the contractor's criminal and financial history. The contractor shall voucher potential employees through reference and employment checks. All Contractor employees/subcontractors who will enter the FCC to perform services shall be required to attend a four-hour institution orientation course held at the FCC or a mutually acceptable site. A refresher orientation must be completed annually. The Contractor’s costs for contract staff to attend this training shall be the responsibility of the Contractor. The Contracting Officer or COR will be responsible for scheduling training for all applicable contract staff.

All Contractor personnel performing services under this contract shall have the ability to read, understand, fluently speak, and legibly write the English language.

At least two weeks prior, the Contractor shall submit a bi-weekly work schedule to the Contracting Officer’s (COR) or designee for reference purposes.

Physical Plant. The Government will provide space adequate to handle twenty dialysis stations and one isolation room. Each station is equipped with four electrical outlets (two emergency and two regular 110 volt outlets), continuous loop water supply, and a nurse call station. In addition, other room(s) with utilities are available for use by the Contractor.

Government-provided Equipment/ Supplies. The Reverse Osmosis Water System is owned by FCC Butner and will be maintained by the FCC during the contract performance. The FCC will provide the following supplies in support of the Contractor’s performance of services: syringes, needles, intravenous catheters, tubing, and medications. The Government will also provide utilities to include heat, light, electric, water, and ventilation to the Dialysis Services Unit. The Government will provide disposal boxes for biomedical waste and contaminated materials generated in the Dialysis Services Unit and will provide the disposal service for such materials.

All other equipment and supplies necessary for performance of the dialysis services shall be provided by the Contractor.

Contractor-provided Equipment and Supplies. The Contractor shall provide the Dialysis Machines/Chairs and one machine/chair to be placed in the isolation area for a total of 20 machines/chairs. The Contractor shall also provide at least five additional backup machines and one portable Dialysis Machine to be used if an AIC needs to be placed in a negative pressure room. All equipment provided by the Contractor shall remain the property of the Contractor and shall be removed promptly by the Contractor at the conclusion of this contract. The Contractor shall provide all maintenance, cleaning, and calibration, in accordance with accepted standards, of all Contractor-provided equipment. All equipment maintenance shall be performed at FCC Butner. All troubleshooting, preventive maintenance, and repairs of Contractor-provided equipment must be performed by qualified personnel. All electrical-powered equipment which have undergone repair or service which might have affected the integrity of the electrical circuits must receive an electrical safety test before being returned to operation. Electrical safety tests must be performed with test equipment that has been properly calibrated.

Specialized equipment and dialysis supplies may be furnished by the Contractor, at no expense to the Government, to enhance the dialysis treatment capabilities at the FCC. Prior to introducing additional equipment and supplies into the correctional environment, however, the contractor shall request and receive approval from the FCC. Such approval is necessary to ensure security and safety and that all biomedical clearances are properly addressed.

All blood transfusion products shall be provided by the Contractor.

The offeror’s technical proposal shall discuss in detail the staffing approach for accomplishing Output #1.

Output #2: Provide FMC-based diagnostic and follow-up evaluations by a Nephrologist which conform to community standards and all local, state, and Federal laws and regulations applicable to the delivery of health care to members of the general public.

General. The Contractor shall provide a Nephrologist to provide diagnostic and follow-up evaluations to recommend treatment, provide clinical management of patients on dialysis, and assume primary responsibility for the operations of the FCC Dialysis Services Unit. The Nephrologist shall conduct weekly Nephrology Clinic(s) for patients referred by FCC physicians.

Patients seen in the weekly Nephrology Clinic(s) will include, but will not be limited to pre-renal, transplant, referrals, etc. In addition, any additional Nephrology Clinics to accommodate overflow of patients, will be negotiated in good faith on a case-by-case basis by the Government and Contractor. The Nephrologist shall also be present in the Dialysis Services Unit for at least one Dialysis Treatment per month for each AIC receiving dialysis. Services shall be provided within the Dialysis Services Unit at the FCC.

Staffing. The Nephrologist shall be a graduate of an American Medical Association (AMA) accredited medical school, have completed an AMA-approved internship/residency in Nephrology, and possess current/active licenses issued by any state within the United States to practice medicine without restrictions.

All physicians performing these services shall apply for clinical privileges at the FCC. Any privileges granted due to the award of this contract shall be contingent upon the continuation of this contract and upon the physician’s continued affiliation with the Contractor or any subcontractor. Continuation of privileges at the FCC shall be at the sole discretion of the FCC.

If requested by the Contracting Officer, the Contractor shall be required to document primary source verification of the credentials for each Nephrologist to include the following: current license from the appropriate State Board of Medical Examiners, education from professional schools or universities, evidence of completion of internships and/or residences, as appropriate.

The Contractor shall ensure that the Nephrologist shall be free of infectious diseases. Any individual performing services under this contract who subsequently develops a medical condition which might reasonably be expected to place other workers or patients at risk shall be immediately removed from activities which might reasonably be expected to place other workers or patients at risk. The Contractor shall ensure that its employees/subcontractors are in compliance with preventive, prophylactic, and follow-up procedures, as well as infection control and employee health program procedures.

The Nephrologist shall only prescribe pharmaceutical drugs that are listed in the approved BOP Formulary. The BOP formulary can be accessed at www.bop.gov/news/PDFs/formulary.pdf.

Requests for exemptions shall be submitted to the COR, who shall obtain the required approvals.

The issuance of sample medication to any Federal AIC shall be prohibited.

All contract personnel providing services within the confines of the FCC shall have a complete background investigation conducted in accordance with BOP Program Statement 3732.01 “BOP Identifications and Background Investigation.” This background investigation will be conducted initially and recur every five (5) years for the duration of the contractor's service. Continued service is contingent upon a favorable adjudication. The background investigation includes but is not limited to a comprehensive check of the contractor's criminal and financial history. The contractor shall voucher potential employees through reference and employment checks. All Contractor employees/subcontractors who will enter the FCC to perform services shall be required to attend a four-hour institution orientation course held at the FCC or a mutually acceptable site. A refresher orientation must be completed annually. The Contractor’s costs for contract staff to attend this training shall be the responsibility of the Contractor. The Contracting Officer or COR will be responsible for scheduling training for all applicable contract staff.

All Contractor personnel performing services under this contract shall have the ability to read, understand, fluently speak, and legibly write the English language.

Output #3: Manage medical record information in a manner which promotes continuity of care while observing restrictions on the release of information.

In order to comply with Privacy Act restrictions, the Contractor shall establish a system of dialysis records on individual BOP patients. This system of records shall be consistent with BOP patient medical records maintained under the usual and customary standards of the medical profession for the purpose of providing treatment records to the BOP medical file.

The BOP shall provide the Contractor access to the Bureau Electronic Medical Records (BEMR) program and any other necessary patient data required to analyze the dialysis needs of the BOP patients. All physicians and other contract clinical staff shall ensure that appropriate documentation is entered into patient medical records which will remain at and are the property of FCC Butner. This shall include pertinent entries in BEMR and on the Standard Form (SF) 600 Chronological History of Patient Care form and the SF-513 Consultation form, implemented upon contingency.

The BOP reserves the right to request the Contractor to review each medical record as deemed necessary. Upon request, authorized BOP staff shall have access to and obtain copies of all dialysis medical records and evaluation and treatment reports prepared and maintained by the Contractor. Medical records will be subject to review by the FCC for validation of payment and verification of services rendered. Release of information shall only be made in accordance with community standards, Joint Commission regulations, and the Privacy Act of 1974. Any request(s) for copies of an AICs Medical Records shall be directed to the COR for processing.

Output #4: Maintain open avenues of communication, facilitating the exchange of information between the contractor and the Government regarding the contract services.

The Contractor shall provide a Point of Contact (POC) who shall be responsible for facilitating the Contractor’s delivery of services under this contract. The POC shall have sufficient clinical knowledge to enable preliminary technical consultation. The Contractor shall designate this individual in writing to the Contracting Officer prior to the start date of the contract. Alternate POC’s may be designated; however, the Contractor must identify those times when an alternate shall be the primary POC.

The Contractor shall submit a quarterly report which includes the following data, at a minimum:

list of AIC, AIC numbers, number of corresponding treatments, total consultations (time and number of AIC), any problems experienced during the quarter, and any other applicable data as determined by BOP. A copy of the quarterly report shall be forwarded by the Contractor to the following individuals by the tenth day preceding the end of the reporting quarter: Health Services Administrator (HSA), Clinical Director, COR, and Contracting Officer.

Output #5: Submit properly priced invoices for services rendered.

Overview. Upon completion of a treatment encounter, the Contractor shall prepare and submit proper invoices for services rendered under this contract. For the purpose of this contract, a specific definition for what documentation constitutes an invoice is provided below. A proper invoice shall include the information specified in FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items, paragraph (g). Services shall be invoiced in accordance with the terms and conditions of the contract, including the payment rate structures specified in the contract.

An invoice for services shall be a paper or electronic invoice detailing the date(s) sessions or treatments were provided, the number of sessions or treatments provided, the unit pricing applied, and the extended total amount due.

V. Special Contract Conditions

In performing the services required by this contract, the Contractor and its employees/subcontractors will have contact with AIC. The Contractor will not be responsible for the management of AIC other than to ensure that those AIC involved in activities within the Contractor’s scope of work shall abide by all rules in effect to ensure their safety and well-being.

The Contractor shall not supervise or discipline any BOP AIC. The Contractor shall adhere to all regulations prescribed by the FCC for safety, custody, and conduct of AIC.

In accordance with FAR clause 52.237-7 titled “Indemnification and Medical Liability Insurance,” the Contractor shall maintain during the term of the contract liability insurance issued by a responsible insurance carrier of not less than $1 million per specialty per occurrence (see the clauses and provisions of this solicitation/contract). If any malpractice suit is made against the Contractor for the treatment of any patient referred by the Government, the Contractor shall immediately notify the Contracting Officer and promptly furnish copies of all pertinent papers received. The Contractor shall authorize Government representative to collaborate with counsel for the insurance carrier in settling or defending the claim when the amount of liability claimed exceeds the amount of coverage.