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DESCRIPTION OF SERVICE /WORK STATEMENT1. GENERAL DESCRIPTIONThe Contractor(s) shall provide Colonoscopy Services for the Department of Veterans Affairs Medical Center (VA/VAMC), 1030 Jefferson Avenue, Memphis, TN in accordance with the requirements of this contract. Colonoscopy is an integral aspect of the care of veteran patients. It may be indicated as a simple screening or surveillance procedure to determine the presence of colon cancer or polyps; or, to investigate the specific symptoms or signs such as constipation or anemia or hemoccult positive stool. In the past few years, the VA has committed to colon cancer screening for quality care, and has set up performance measures to encourage compliance.The current capacity of the Memphis VAMC is far less than the needs of a full colon cancer screening program. VAMC Memphis projects an estimated 3,000 patients will require colonoscopy services each year above the current capacity. These patients will be referred to the awarded contractor(s). Multiple contracts may be awarded. The Contractor(s) shall be located within a 100 mile radius of the VA Medical Center, Memphis, TN, providing services in one or more locations as detailed in the Schedule of Services. Contractors do not have to provide an offer for each community / site. Although this may be a multiple award contract, the contractor that receives an award will be the sole recipient for that particular geographic location.Contract bids should be all cost inclusive, including professional fees, facility fees, monitoring and sedation fees, and shipping costs. The contracted price is for completed procedures. A "No Show" patient is defined as failure to keep a scheduled appointment without canceling that appointment at least 48 hours earlier. Notification of patients that "No Show" for procedures will be reported weekly (each Friday) by fax to the attention of GI Clinic (Joyce Young), fax number (901-577-7286), contact phone number (901-523-8990 ext. 6610), preferably in Microsoft excel worksheet format sorted by referring physician name for follow-up by patient's primary care physician for rescheduling if needed.2. REQUIREMENTSContractor shall provide colonoscopies, inclusive of CPT codes 45378-45385 and attendant procedures (CPT 45330), as clinically needed. It is anticipated that all applicable procedures for a given patient will be performed in a single session. Repeat procedures, if indicated, will be cleared and scheduled by the VA as a new session. Repeat sessions include a small number of cases where the prep was poor, or there were too many polyps to remove in one session, or incomplete removal of a polyp warranted repeat examination.All procedures shall be accomplished at an accredited endoscopy facility that has the proper equipment and supplies necessary to safely perform the required services. Accreditation by either the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (Accreditation Association or AAAHC), or the Joint Commission is required, All endoscopes must be cleaned, reprocessed, and stored according to manufacturer's guidelines.All procedures shall be performed by ABIM board-certified gastroenterologists, or board-eligible gastroenterologists with a minimum of one year of endoscopy experience post-training.Sedation preference will be at the discretion of the contract endoscopist. Options include benzodiazepine plus narcotic versus diprovan alone. All procedures will be performed using accepted clinical standards (see ASGE guidelines referenced below).No outside prescriptions will be necessary. If the contract endoscopist recommends a prescription medication, they must contact Ms. Martha J. Garner at the VA (901-523-8990, ext. 5573) though which the prescription will be administered.3. EMERGENCY MANAGEMENTIn cases of extreme emergency (cardiac arrest, shock, etc.) the closest available medical facility should be used, and the VAMC will be liable for that expense, until such time as the patient is stable enough for transfer to the VAMC. In less extreme cases, such as perforation or modest bleeding (not in shock), transfer to the VAMC Emergency Room should be arranged unless there is medical contraindication.This should not pose a medical problem for Contractors located within the city, but may for outlying areas. If Contractor is unsure of what to do, contact Ms. Martha Gamer or Ms. Cecilia Bird at 901-523-8990, ext. 5573.4. RESPONSIBILITIESThe Contractor shall provide colonoscopies, inclusive of CPT codes 45378 — 45385 and attendant procedures, as clinically appropriate.The Memphis VAMC will be responsible for pre-procedure patient education and scheduling, and all post procedure care (except extreme emergencies), including pathology interpretation. VAMC Memphis will also be responsible for subsequent management of any diagnosis requiring follow-up care.5. PROCEDUREVAMC Memphis - VAMC Memphis will identify suitable patients and perform the initial patient education, provide prep materials and instructions, and obtain routine laboratory tests if indicated. Note that the colon cleansing procedure of choice at VAMC Memphis is currently polyethylene glycol. Pre-procedural patient education and preparation alternatives from the Contractor(s) will be considered based on good medical practice.Patient colonoscopies will be scheduled with the Contractor(s) by VAMC Memphis. VAMC Memphis will send all necessary clinical information, such as history & physical, progress notes, and/or consult sheet to the Contractor's facility via fax (if Contractor's fax is secure and turnaround is short) prior to the procedure. Direct phone contact with the appropriate VA areas (GI Lab or business office) will be provided if information is not available.Post-procedure, Memphis VAMC will perform histology and pathologic interpretation of tissue samples obtained and provide care for any complications that may occur. Subsequent treatment of any diagnosis requiring follow-up care will be provided by VAMC Memphis. Procedural records from the contractor will be scanned or otherwise transferred into the VA electronic medical record by VAMC staff. VAMC Memphis will reimburse the Contractor for services provided based on the agreed, all-inclusive, contract price.Contractor(s) - The Contractor(s) shall obtain the consent, administer sedation, perform the procedure, recover the patient, and discharge the patient using safe sedation practices and in accord with good professional practice (ASGE guidelines). All tissue specimens obtained during the procedure will be forwarded to VAMC Memphis for processing and interpretation (see Section 6). The Contractor physician and staff shall instruct the patient on possible delayed complications and contact methods for procedure- related problems. The Contractor shall manage initial phone calls regarding minor problems related to the procedure and perform random post-procedure satisfaction surveys of veterans for annual submission.The contract physician shall also provide VAMC with sufficient documentation for both the patient medical record, quality monitoring, and for insurance billing purposes (see Sections 6 and 8). VAMC Memphis will bill the insurance company, where applicable, based on documentation submitted by the contract physician. The Contractor cannot bill insurance companies for any services provided to contract VA patients. All patient information matters will be subject to the Privacy Act of 1974 and HIPAA regulations.6. PATIENT SELECTION FOR CONTRACT COLONOSCOPY REFERRAL:Indications for Contract Colonoscopy:Colon cancer screening (age <80).Routine surveillance of adenomatous colon polyps.Family history of colon cancer or adenomatous polyps.Hemoccult positive stool on home screening.Chronic constipation without abdominal pain or weight loss or bleeding Weight loss without GI symptoms or bleeding.Normocytic anemia without iron deficiency.Contraindications for Contract Colonoscopy: Age >80.Coumadin anti-coagulation or known coagulopathy. Valvular heart disease, h/o endocarditis, pacemaker, Unstable angina or cardiac work-up in progress Advanced heart failure (NYHA Class III or IV). Advanced lung disease (home 02, SOB at rest) Advanced liver disease (ascites, encephalopathy) Advanced renal disease (creatinine >2.5)Terminal condition (e.g., advanced AIDS, cancer)Active GI complaints (abdominal pain, diarrhea, change in bowel habits, bleeding)Iron-deficiency anemia.Inability or refusal to provide informed consent7. CLINICAL INFORMATION AND SPECIMEN DELIVERYProcedure reports and other procedure documentation should be sent the same day to the VA, either by HIPAA-secure Fax or by VA courier (VA courier will be available to Memphis area contractors only). Fax number and VA courier contact information will be provided by the VA Contracting Officer's Technical Representative (COTR) prior to the initiation of the contract.All specimens must be appropriately labeled with the patient's full name, full social security number, date, and clinical information, and be accompanied by VAMC Pathology Form 515 (tissue exam), which will be provided. All pathology specimens will be placed in containers containing formalin provided by VA Memphis Pathology Service. Specimen containers are to be placed in specimen bags containing absorbent pads. VA Form 515 with the patient’s full name and social security number will be placed in the pouch on the outside of each specimen bag. Specimens from Memphis area locations will be picked up by VA courier on a daily basis. The Contractor is to contact the VA transportation office (901-523-8990, extension 5668) for pick-up. Specimens from locations outside of Memphis will be placed in a small shipping box (multiple specimen bags may be placed in same box) and shipped by overnight courier to VAMC Memphis, Att: Pathology Service Room 113, 1030 Jefferson Ave, Memphis, TN 38104. Pathology Service contact number is 901-523-8990, extension 5498. Transported specimens do not need to be refrigerated. ALL shipping costs should be included in the cost of doing the procedure.As contract agents, the physicians, facility, and staff must possess adequate malpractice insurance coverage. The VA does not provide tort-claim coverage for contract activities. The facility shall either be an accredited outpatient ambulatory surgery center or a hospital based (JCAHO accredited) unit that can perform Gastroenterology procedures. VAMC reserves the right to inspect and approve all contract site(s).8. MEDICAL RECORD REQUIREMENTS/RELEASE OF INFORMATIONPre-Procedure and Sedation Documentation: The contract physician shall provide VAMC Memphis with sufficient documentation for both the patient medical record, quality monitoring, and insurance billing. The Contractor shall provide an appropriate pre-procedure note from the physician and sedation records. Such notes shall include at a minimum:The appropriate level of documentation consistent with an E&M Code of 3, 4, or 5.An evaluation of the patient's pain level based on a 0-10 scale with 10 as the most severe. Patients with a pain level of 3 or more will require further evaluation of their pain.A measurement of the patient's vital signs including blood pressure, heart rate, and oxygen saturation before, during, and after the procedure.Procedure Report Documentation: Appropriate procedure reports shall contain both a description of the findings and a detailed account of techniques used and tissues removed and the name of the primary surgeon and any assistants. Any correspondence regarding the patient should be addressed with the patient's full social security number.All of the above documentation must be faxed or transported by VA courier or private courier to VAMC Memphis in a sealed envelope, the same day as the procedure. If private courier is used, the Contractor shall incur the cost of courier service. Photos with proper labeling (patient name, social security number, date, and description) should be mailed to GI Lab, VA Medical Center, 1030 Jefferson Ave., Memphis, TN 38104 or sent by VA courier. Records will then be scanned or otherwise transferred to the VA electronic medical record. The Contractor shall telephone the Contracting Officer's Technical Representative (COTR) at 901-523-8990 ext. 5573 to report urgent or STAT findings and fax the report immediately to the number designated by the COTR. The VAMC will bill the insurance company, where applicable, based on the documentation submitted by the contract physician. No other billing by the Contractor is permitted.All patient information matters will be subject to the Privacy Act of 1974 and HIPAA. The Contractor, Contractor's employees, and subcontractors (if applicable) shall be subject to the Privacy Act of 1974 and HIPPA. The Contractor is not authorized to release any medical record information. VAMC Memphis is the sole entity authorized to release this information upon written request submitted via facsimile or mail from the patient. VAMC Memphis provides the Contractor with access to pertinent patient medical information within existing privacy rules and regulations for the purpose of coordinating care. Contractors shall ensure the confidentiality of all patient information and shall be held liable in the event of a breach of confidentiality. The contractor will advise patient of presumptive findings, especially as relating to post- procedure cautions and instructions and annotate on the colonoscopy report "the results of colonoscopy were verbally discussed with patient prior to departure". The Contractor may also provide Return-To-Work statements, exclusive of diagnosis and other private information. The patient may also be provided written post-procedure instructions. Release of any procedure reports or clinical notes to the patient or to outside sources (other than what is allowable in this paragraph) is not permitted. VAMC Memphis will contact the patient with pathology findings. Any release of information beyond direct physician/nurse verbal interaction related to the procedure must be channeled through VAMC Memphis and the patient must sign a VAMC Release of Information form.The Contractor shall maintain a single comprehensive record of each patient. Each record must be legible and maintained in detail consistent with good medical and professional practice, which permits effective internal and external peer review and/or medical audit and facilitates an adequate system of follow-up treatment.9. MONITORING AND RECORD KEEPINGACTIVITYSTANDARDMINIMUM MONTHLY COMPLIANCE STANDARDIdentificationFull patient name and social security number100% complianceProcedure Reports CompletionProcedure reports shall contain prep quality, description of all findings including hemorrhoids, a detailed account of techniques used, tissues removed, and the name of the endoscopist and assistants. A copy of the pre-procedure note and conscious sedation form is also required.100% compliancePathologic and other SpecimensSpecimens will bepacked and transported to VA appropriately100% compliance10. PERFORMANCE STANDARDSPerformance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). Contractors must adhere to Joint Commission Standards.Contractor must accept all patients assigned by the Memphis VA Medical Center.TaskIDIndicatorStandardAcceptable Quality LevelMethod of SurveillanceDeductionTimely Access1 Timely appointments are scheduled according to contractual agreementsPatients must have acolonoscopy appointment within 30days of scheduling95% Scheduled according to contractMonthlyreview of wait times for next available appointment by CORExercise of Option PeriodPatient Satisfaction2Acceptable levels ofPatient SatisfactionSatisfaction level will be good or excellent on survey95% Patient SatisfactionPost-procedure survey of veterans by contractor,annual report to CORExercise of Option PeriodQuality Care3Provider Complication RatesRates as defined by AGA*At or below national averagesReview of all majorcomplications by clinical consultant to CORTermination of contract if excessive11. Certification and Accreditation Authorization The C&A requirements do not apply to this contract and therefore a Security Accreditation Package is not required.12. REFERENCES Sedation and anesthesia in GI endoscopy. 2008. Gastrointest. Endosc. 88:215-826.Standards for Office-based GI Endoscopy Services. 2001. Gastroenterol. 121:440-443.* Complications of colonoscopy.2003. Gastrointest. Endosc. 57:441-445.SCHEDULE OF SUPPLIES/SERVICES AND PRICES/COSTS (SF 1449, Continuation of Blocks 19 — 24)Under the authority of Public Law 104-262 and 38 USC 8153, the Contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans Affairs (VANAMC) medical facility, the services and prices specified in the Section entitled Schedule of Supplies/Services of this contract.See accompanying workload assessment. Projected annual total number of screening colonoscopies is 4,500/yr. Current capacity is —1,500. Therefore, the estimated additional required capacity by contract is 3,000. We estimate the breakdown by geographic areas to be:Area One:Memphis 60% (1,800)Area Two:Dyersburg 10% (300)Area Three:Jonesboro10% (300)Area Four:Oxford/Tupelo10% (300)Area Five:Jackson10% (300)LINE ITEMDESCRIPTIONCPT CODEEST QTYUNITUNIT COSTTOTAL COST?1Colonoscopy45378___Each$_____________$ ________________2Colonoscopy w/ Biopsy45380___Each$_____________$ ________________3Colonoscopy w/ Hot Biopsy45384___Each$_____________$ ________________4Colonoscopy w/ polypectomy45385___Each$_____________$ ________________5Flex Sigmoidoscopy45330___Each$_____________$_______________6Colonoscopy with Tattooing45381___Each$_____________$_______________Sub-Total for Line 1 through 6: $__________________ ................
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