DOCUMENT
65 -- Artifical Limbs - Attachment
- Notice Date
- 8/21/2014
- Notice Type
- Attachment
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of Veterans Affairs;Wilkes Barre VAMC;Acquisitions (049E);1111 E End Blvd;Wilkes Barre PA 18711-0030
- ZIP Code
- 18711-0030
- Solicitation Number
- VA24414Q1466
- Response Due
- 8/28/2014
- Archive Date
- 9/27/2014
- Point of Contact
- Kevin Balser
- E-Mail Address
-
kevin.balser@va.gov
(kevin.balser@va.gov)
- Small Business Set-Aside
- Partial Small Business
- Description
- This is a sources sought notice and not a solicitation. 1.0.Background The Department of Veterans Affairs (VA) provides prosthetic limbs and related services to veterans who are eligible for VA health care services and have medical needs for such items and services. This acquisition will supplement VA in providing comprehensive prosthetic care and support to the veterans in need. It is VA's intent to solicit proposals and award multiple contracts. 2.0.Scope The Contractor shall fabricate all prosthetic limbs in strict conformance to the prosthetic prescription that has been provided by the VA Amputee Clinic Team. The VA will provide a list of approved L Codes for work to be provided by the Contractor for the specific prescription. The Contractor shall not add or substitute components or alter the veteran's limb prescription in any way without prior approval and written authorization from the Contracting Officer (CO). The solicitation only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation. 3.0.Education and Training Requirements 3.1.General Education The Contractor shall have a full-time American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) certified, or Board of Certification/Accreditation International (BOC) certified prosthetist(s) on staff in "good standing" at each of the proposed service locations throughout the contract period. "Good standing" is defined as participating and achieving appropriate continuing education credits and paying dues as determined by Certifying Agency such as ABC and BOC. VA reserves the right to verify prosthetists' credentials anytime during the term of this contract. The Contractor shall provide current copies of certifications upon request of the COR. Failure to comply with this requirement may lead to adverse actions by the Government up to, and including contract termination in accordance with the contract clauses in the contract. 3.2.Special Education Requirements for Certain Prosthetic Limb Devices/Components The fitting and alignment of prosthetic limbs device and associated services shall be performed under the supervision of a prosthetist who has met the applicable educational and training requirements covered under the manufacturing training program for that device. New technologies require proof of training and only those prosthetists specifically trained, or completing training for purposes of providing an item by the time of delivery of the item may provide the item and follow up services to a veteran. VA reserves the right to determine which technologies require specific training. VA will notify the Contractor when current technologies require specialized training from the manufacturer in order to provide to veterans. 4.0.Specific Requirements 4.1.Compliance with VA Prescription and Coding of Prosthetic Limb Devices/Components The Contractor shall not add or substitute components or alter the veteran's prosthetic limb prescription in any way without prior approval and written authorization from the CO. Any changes to the veteran's prescription, components or codes require review and approval by the VA Amputee Clinic Team and shall be authorized in writing by the CO. 4.2.Contractor Facility Locations All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this contract shall be listed in the proposal. All work required under this contract shall be conducted at the facility locations included in the contract. The Contractor's facilities shall be accredited either by the Facility Accreditation Program of the ABC or the Accredited Facilities Program of the BOC at the time of proposal submission. VA reserves the right to conduct site visits of the facility and review accreditation and certification documents and standards at any time. The Contractor shall provide current copies of accreditation documents upon request of the COR. VA may conduct site visits as needed by the COR and other VA subject matter experts as determined by the COR. Throughout the duration of this contract, the Contractor shall notify VA of any facilities that are added, changed, or closed to the CO and the COR within 15 calendar days of any change. Approval for added or changed facilities must be obtained before those facilities may be used for this contract. 4.3.The Joint Commission and Other Special Requirements The Contractor shall perform the required work in accordance with the Joint Commission (TJC) and ABC and/or BOC standards. All Contractor employees shall continuously meet or exceed TJC and ABC and/or BOC standards. The Contractor shall develop and maintain the following documents for each contractor employee working on this contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully, and including knowledge and skills required to provide care for certain patient populations, as appropriate); a current performance evaluation supporting ability of the contractor employee to successfully perform the work required under this solicitation; and, listing of relevant continuing education for the last two years. At the time of contract award, annually on the date of the contract award thereafter, and at any other time requested by the VA COR, the Contractor shall provide current copies of these records for each contractor employee working on this contract. The Contractor shall be responsible for ensuring that contractor employees providing work on this contract are fully trained and completely competent to perform the required work. When changes in contractor personnel are approved in accordance with the "Key Personnel" clause of the contract in section 5.1, the Contractor shall provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above. Where the contract does not require TJC accreditation or other regulatory body requirements, the Contractor shall perform the required work in accordance with TJC standards. A copy of TJC standards can be obtained from The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181 or http://www.jointcommission.org/. 4.4.Outcome Monitoring and Utilization VA may prescribe and authorize an automated prosthetic utilization and function monitoring device for data collection and analysis for a new lower extremity prosthetic limb (transtibial, knee disarticulation, transfemoral and hip disarticulation level; does not include socket replacements). The utilization and function monitoring device will have the ability to record intensity, endurance, gait symmetry, dynamic function, including alignment, forces and moments with proven accuracy. The device will monitor and continuously record the following: "Stance and swing time for gait symmetry, dynamic function including alignment, forces, and moments; "Cadence and cadence variability; "Step count - continuous recording of total step count; "Number of steps per selected time interval; "Longitudinal, historical and objective analysis; "Peak performance index, quantifiable into baseline and faster than baseline rate of walking, distance and variable cadence; "Functional level assessment capability; and "Measurement of socket load during gait. VA may request "Veteran Outcome Reports" based on the data collected. The report shall contain narrative and graphical representation of the above variables. 4.5.Semi-Annual Service The Contractor shall provide semi-annual service to each veteran for whom the Contractor is managing prosthetic limb care. For the purposes of this contract, semi-annual service is defined as a follow up visit for inspection of the prosthetic limb(s) and evaluation for fit and function for all VA-approved prosthetic limb(s) the patient owns and is actively using. Typically, semi-annual service includes inspection, testing, cleaning, and checking of the prosthetic limb(s) and/or residual limb(s) to include maintenance specific to the warranty of devices. Semi-annual service shall not be incumbent upon the number of prosthetic limbs a patient owns. Two follow up visits per patient are required annually for a patient to whom the Contractor delivered a prosthetic limb(s) under this contract. The Contractor shall notify the CO for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the veteran. The following L-Code shall be used for semi-annual service: "L7520 - Repair prosthetic device, labor component, per 15 minutes (not to exceed 4 units or 60 minutes) 4.6.Warranty The Contractor shall warrant the prosthetic limb provided against defective material and/or workmanship for a minimum of 90 calendar days from the date of acceptance by VA. The minimum warranty period shall commence after the final check out at the VAMC by the Amputee Clinic Team and deliverable acceptance by the CO. Manufacturer's warranties of prosthetic limb and limb devices/components that extend beyond the minimum 90 calendar day period shall be in effect and be enforced. The Contractor shall furnish, without additional cost to the Government, all materials and labor necessary to correct defects that were detected during the warranty period. These conditions do not apply to adjustments incidental to wearing of the prosthetic limb, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the Contractor. Any prosthetic limb repaired or furnished as a "loaner" shall be subject to this clause to the same extent as a new prosthetic limb delivered. The warranty for a repaired limb or "loaner" limb shall be equal in duration to the term the Contractor is required to offer to a new prosthetic limb and shall run from the date of the acceptance of the repaired or "loaner" prosthetic limb by VA. The Contractor shall warrant and imply that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract. The rights and remedies of the Government provided in this clause are in addition to, and do not limit any, rights afforded to the Government by any other clause of the contract. 4.7.Repair and Replacement 4.7.1.Minor Parts of Prosthetic Device and Labor All parts procured or fabricated to replace existing parts or to modify a previously issued or fabricated device is considered a "repair," regardless of who fabricated or supplied the original part. Repair and replacement of minor parts may require adjustments to a prosthetic limb required by wear or a change in the veteran's condition. A minor repair or replacement means repair or replacement that does not significantly alter the function or essential physical characteristics of an item or component, or change the purpose of an item or component. Factors that will be considered in determining whether a repair or replacement is minor include the value and size of the repair or replacement, and the comparative value and size of the final product. Dollar values and percentages may be used as guideposts, but are not conclusive evidence that a repair or replacement is minor. The following L-Codes shall be used for repair and replacement of minor parts and for labor: "L7510 - Repair prosthetic device, repair or replace minor parts (not to exceed $500.00) "L7520 - Repair prosthetic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes) Repair and replacement of minor parts and labor requires prior approval and written authorization from the CO, except for repairs provided to veterans with VA Prosthetic Service Card (VA Form 10-2501) as described in section 4.7.2. 4.7.2.Use of Prosthetic Service Card (VA Form 10-2501) Veterans may obtain repair services using a VA Prosthetic Service Card (PSC) VA Form 10-2501. A PSC is a pre-authorized card that can be used to receive needed repairs to the veteran's qualified prosthetic device up to the amount indicated on the PSC. For prosthetic limbs, veteran may obtain repairs up to $500.00 with the PSC. For repairs or replacement of parts other than using a PSC or over $500.00 shall be completed with prior approval and written authorization from VA and in accordance with the section 4.7.1. The Contractor shall submit VA Form 10-2520 PSC Invoice (Attachment A) to the Prosthetic and Sensory Aids Service at the VAMC with the primary service area responsibility where the veteran resides for reimbursement. The Contractor shall obtain the veteran's signature acknowledging receipt of appropriate repair for invoices for such repairs under the authority of a PSC. 4.7.3.Other than Repair or Replacement of Minor Parts of Prosthetic Device and Labor Repairs to a prosthetic limb are covered when necessary to make the prosthetic limb functional. If the expense for repairs exceeds the estimated expense of purchasing a new prosthetic limb or device, no payment can be made for the amount of the excess. Maintenance that may be necessitated by manufacturer's recommendations or construction of the prosthetic limb shall be performed by the Contractor covered as a repair. Replacement of a prosthetic limb or replacement of a prosthetic limb device/component requires prior approval and written authorization from the CO. Replacement of a prosthetic limb or prosthetic limb device/component will be initiated if the VA provider (i.e., Amputee Clinic Team or VA provider) with granted prescription authority, and who is involved in veteran's amputation care, prescribes a prosthetic limb or device for the following reasons: (1)A change in the physiological condition of the patient; irreparable wear of the device or part of the device; or the condition of the device, or part of the device, requires repairs and the cost of such repair would be more than 60% of the cost of a replacement device, or of the part being replaced. (2)Damage to the prosthetic limb or device is not due to malicious damage, culpable neglect, wrongful disposition or use of device other than intended purposes. 4.8.Government Supplied Items VA may provide certain supplies such as shrinkers, liners, sleeves, and socks to the veteran at the discretion of the VA. Any items or supplies provided to the veteran by the Contractor shall be pre-authorized by the CO. 4.9.Loaner Prosthetic Limb Requirements The Contractor shall be qualified to furnish prosthetic devices such as, but not limited to, hydraulic knee units, micro-processor feet and knees, electronic hands and feet by completing special educational and training requirement for such devices as described in section 3.2 and the same requirement shall be applied to provision of a "loaner" unit. The Contractor shall provide a "loaner" unit in the event that a veteran's prosthetic limb requires repair by the manufacturer. A "loaner" is defined as a suitable prosthetic device, fit for patient use during the repair period. VA will not reimburse for loaner units. 4.10.Recalls The Contractor shall immediately notify all affected VAMC(s) and COR(s) in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Contractor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification: "A complete item description and identification; "Administrative identification data including contract number, order numbers and order date; "Removal, adjustment, or modification reasons for recall; and "Instructions for appropriate corrective action. 5.0.Special Contract Requirements 5.1.Key Personnel and Temporary Emergency Substitutions The Contractor shall assign the following key personnel to this contract: all individuals providing items and related services to veterans and for whom information about education and training is required to be submitted as a part of the response to this solicitation including, but not limited to, those individuals who must meet the training requirements set forth in the Education and Training Requirements in Section 3.0. During the first ninety (90) calendar days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within fifteen (15) calendar days after the occurrence of any of these events and provide the following information: "Detailed explanation of the circumstances necessitating the proposed substitution; "Complete resume for the proposed substitute; and "Any additional information requested by the CO. Proposed substitutes shall have comparable qualification to those of the persons being replaced. The CO will notify the Contractor within fifteen (15) calendar days after the receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel. In the case where VA does not agree with the proposed substitutes and their qualifications, the contract may be terminated and the Contractor may not receive the minimum dollar amount specified in this contract. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person being replaced temporarily. Any substitution exceeding a period of two weeks consecutively shall follow the key personnel replacement procedure described in paragraph above. 5.2.Confidentiality of Patient Records The Contractor shall develop or operate a system of records on individuals, to accomplish an agency function subject to Title 5 United States Code (USC) 552a. Violation of the law may involve the imposition of criminal penalties. The Contractor may be required to enter into a Business Associate Agreement. The Contractor is a VA contractor and shall assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. The contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA 's records, at VA's place of business on request during normal business hours, to inspect and review and make copies of such records. Records created by the contractor in the course of treating VA patients under this contract are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Upon the expiration of this contract or termination of the contract, the contractor shall promptly provide the VA with the individually identified VA patient treatment records. In any instance where the contractor transmits patient or sensitive data of any sort to VA, the contractor shall encrypt the data and provide it in an encrypted/secured manner. 5.3.VA Sensitive Information a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. 5.4. Security Incident Investigation a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 5.5 Liquidated Damages for Data Breach a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); 6.0.Performance, Delivery, Inspection and Acceptance 6.1.Performance and Delivery The Contractor shall complete initial delivery of items ordered under this contract no later than 30 calendars days after receipt of a delivery order. Initial delivery means an ordered item or service is complete and the item is provided to, and accepted by the patient. The Contractor shall provide a written notification to the CO within 7 calendar days of the receipt of a delivery order to show cause in the event the Contractor is unable to deliver the required items or services in accordance with the Government's required delivery date. Initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government. In the event the Government desires expedited delivery, the CO shall telephonically contact the Contractor and inquire into the feasibility of obtaining the device under this condition. The Contractor shall respond within 24 hours to such request and expedited delivery shall be mutually agreed upon. Expedited delivery terms and conditions, when required, shall be determined by the CO or COR and the Contractor on a case by case basis and stated in the individual task or delivery order. Any additional costs incurred by the Contractor for meeting this requirement shall be negotiated in accordance with 48 U.S.C. 52.212-4, Contract Terms and Conditions - Commercial Items. The total cost for the expedited delivery shall not exceed 1.5 times the cost of the normal delivery for the same or similar item with any applicable discounts. Failure by the Contractor to deliver the ordered items on an expedited basis, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the CO shall undertake any action authorized pursuant to the awarded contract, or otherwise in accordance with applicable statutes and regulations. 6.2.Inspection and Acceptance Contractor performance shall be monitored by the Quality Assurance Surveillance Plan (QASP) located in Section A. The QASP matrix details performance indicators, the standard, the acceptable quality level, the method of surveillance and incentive/disincentives. The indicators are: "Delivery time requirement "Limb compliant with VA physician prescription "Workmanship free of defect (socket fits appropriately, limb correctly aligned) "Patient education "Patient acceptance of the device in all aspects (cosmetically and functionally) Payment shall be rendered for a prosthetic limb or service that satisfactorily meets all of the indicators. Payment shall be delayed for any prosthetic limb or service that does not meet one or more of the indicators. The Contractor shall correct all deficiency of non-compliant prosthetic limb or service within fifteen (15) calendar days of written rejection notification from the COR. The corrected prosthetic limb or service will be re-inspected for acceptance. No invoice shall be submitted until the Government accepts the item or service. For new prosthetic limbs or socket replacement for existing prosthetic limbs, final check-out by the VA Amputee Clinic Team at the VAMC from which the task order was generated is required. Final delivery and check out shall be conducted at the VAMC, either by in person inspection or via Tele-health capabilities at an outlying VA facility. Final acceptance or rejection and authorization for payment shall occur with the final delivery and checkout of the prosthetic limb to ensure accuracy of prescription and acceptance by the veteran. CO will provide a written acceptance notification for any items accepted by the Government. Veteran prosthetic limb wearers may be measured and fitted and accept conditional or initial delivery of the prosthetic limb at the Contractor's facility. However, conditional or initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government and authorization for payment. Repair or replacement of prosthetic limb components other than socket replacement does not generally require final check-out by the VA Amputee Clinic Team unless VA determines and notifies the Contractor that the final check-out is required with the issuance of the task or delivery order. VA retains sole discretion to determine whether a final check-out is necessary for the task order. 7.0.Ordering Procedures The Contractor shall not directly, or indirectly through agents, solicit eligible veterans. VA personnel shall not direct, guide or prompt a veteran to a specific contractor except when a physician determines that it is a medical necessary as documented in clinical notes. Veterans are allowed to select a non-VA prosthetic limb provider from a list of VA approved contractors and this satisfies the requirement for fair opportunity. In some instances a VA clinician determines that it is medically necessary to select a certain contractor as documented in clinical notes, which would also satisfy the fair opportunity requirement of FAR 16.505(b)(1). Exceptions to the fair opportunity process are: "The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays. "Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. "The order must be issued on a sole-source basis in the interest of economy and efficiency because it is logical follow-on to an order already issued under the contract, provide that all awardees were given a fair opportunity to be considered for the original order. "It is necessary to place an order to satisfy a minimum guarantee. "For orders exceeding the simplified acquisition threshold, a statue expressly authorizes or required that the purchase be made from a specified source. "In accordance with section 1331 of Public Law 111-240 (15 USC 644(4)), contracting offers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3). When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply. ABBREVIATIONS: ABCAmerican Board for Certification in Orthotics, Prosthetics & Pedorthics BOCBoard of Certification/Accreditation International CMSCenters for Medicare and Medicaid Services COContracting Officer CORContracting Officer's Representative DMEPOSDurable Medical Equipment Prosthetics, Orthotics, and Supplies FARFederal Acquisition Regulation HCPCSHealthcare Common Procedure Coding System HIPAAHealth Insurance Portability and Accountability Act NOCNot Otherwise Classified or Specified PSCProsthetic Service Card QASPQuality Assurance Surveillance Plan TJCThe Joint Commission VADepartment of Veterans Affairs VAMCVA Medical Center USCUnited States Code
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