VHA provides health care services to veterans at VHA’s 152 VAMCs and associated outpatient clinics. Such care can include providing surgical implants, where required—including biological implants, such as skin grafts, and non-biological implants, such as cardiac pacemakers.Surgeons and other clinicians at VAMCs determine veterans’ needs for surgical implants and provide VAMC prosthetics purchasing staff with documentation showing which item will be implanted in the veteran or has already been implanted in the veteran (if the surgery has been completed). The prosthetics purchasing system is used to record the purchase of all prosthetics, including surgical implants. Clinicians at four VAMCs cited patient need and their clinical expertise in using available surgical implants as the most important factors influencing their decisions of which surgical implants to use. In addition, certain clinicians stated that the availability of committed use contracts also influenced their decisions, whereas the availability of FSS contracts generally did not. Many clinicians we interviewed at the four selected VAMCs stated that the specific needs of the patient were one of the two main factors that influenced their decision of which surgical implant to purchase and use. Clinicians stated that even though different types of surgical implants may appear to be identical to the lay person, there may be differences that can affect patient outcome. For example, one clinician stated that a flexible stent available through only one vendor was necessary to meet the needs of a patient with arteries that were difficult to navigate. Many of the clinicians we interviewed stated that the other main factor influencing their decision of which surgical implant to use was their clinical expertise, which they acquired through their training and clinical experience, review of relevant literature, and interaction with vendors who supply surgical implants: Training and experience: Many clinicians we interviewed stated that their experiences in using certain types of surgical implants during their medical training and/or as a practitioner significantly impacted their decision of which item to purchase and use. For example, one clinician stated that his knowledge of different types of surgical implants, including the different features of various implants, is the result of 30 years of training and experience. Review of relevant literature: Several clinicians stated that they regularly reviewed relevant literature to help identify the surgical implants with the greatest clinical efficacy. One clinician told us that he recently switched to a different type of skin graft because a review of the literature suggested that this item was more effective than the one that he had been using. Interaction with vendors: Several clinicians told us that they work closely with vendor representatives who supply surgical implants (for example, when implanting a pacemaker, a vendor representative may be involved in testing and programming the device). Further, some clinicians with whom we spoke said that their past experience working with a particular vendor, including whether they believe that the vendor representative is knowledgeable and reliable, helps drive their decision of which implant to use. For example, a clinician stated that the reliability of vendors was important in deciding which implant to use, since some implants are not stocked at a VAMC and it is important that implants are delivered by vendors in time for scheduled surgical procedures. Clinicians who performed surgical procedures for which implants were available on a national committed-use contract stated that they typically used one of the implants available on this type of contract, unless the use of these items was not appropriate, for example, for certain complex clinical indications. As of September 2013, nine types of surgical implants—cardiac pacemakers and leads, implantable cardioverter- defibrillators, cardiac resynchronization treatment devices, remote monitoring devices, coronary stents, artificial hips, artificial knees, cochlear implants, and intraocular lenses—were available through national committed-use contracts. In developing national committed-use contracts, VHA solicits input from a group of VHA clinicians to determine which items to place on national committed-use contracts and to review them for clinical efficacy. Several different models of each type of implant are available on national committed-use contracts—for example, the contracts for pacemakers include models from three different vendors—thereby providing clinicians with a choice of which implant to use. In 2011, VHA established a program executive office, including six program management offices. Each of the six program management offices (surgery, medical, clinical support, ancillary, advanced systems, and prosthetics) is expected to collaborate with teams of clinicians and other stakeholders, who can provide insight on identifying certain medical devices for standardization. The program management offices also coordinate with VA’s contracting offices, which are responsible for establishing national committed-use contracts for standardized items. a plan or timeline for establishing new contracts. Without the establishment of national committed-use contracts for a greater number of surgical implants, VHA is not fully leveraging its purchasing power as one of the nation’s largest health care systems. While availability of implants via national committed-use contracts positively influenced their use by clinicians we interviewed, the availability of implants via FSS contracts rarely did so for a number of reasons. Clinicians at the four VAMCs we visited were often not aware of what surgical implants were available on an FSS contract, even though these contracts are preferred to open market purchases under the VAAR. For example, some of these clinicians mistakenly believed that a biological implant they were using was on an FSS contract, when in fact it was not. Clinicians at the four VAMCs we visited also lacked awareness of how to obtain information on which implants were available on an FSS contract. In addition, network prosthetics purchasing officials told us that it is difficult for both clinicians and prosthetics purchasing agents to use VHA’s national database of FSS contracts to determine what specific items are available on an FSS contract. For example, the officials stated that very specific terms must be entered in the database’s search field in order to obtain a useful list of items available on FSS contracts. Some clinicians stated that it would be helpful to have a user-friendly list of surgical implants available on FSS contracts, including the implant’s attributes— such as its shelf life and approved clinical indication—for each surgical specialty. Clinicians at the four VAMCs we visited noted that such a list would allow them to consider FSS contract availability in making their decisions on which implant to use. We found that one VAMC we visited had begun developing a list of skin grafts available on FSS contracts, which included their attributes—such as whether the grafts had to be stored in a freezer—to help raise awareness of items available on FSS contract. Some clinicians at the four VAMCs we visited also stated that if there is not sufficient data to support the clinical efficacy of an implant on an FSS contract, they would not feel comfortable using it. For example, at one VAMC, a clinician noted that a specific vendor who had an implant on an FSS contract questioned why the implant was not being purchased. The clinician asked for clinical efficacy data, which—according to the clinician—was never provided, and therefore the clinician decided not to use the item. Senior VHA prosthetics and contracting officials stated that clinicians are not involved in determining which surgical implants should be available on FSS contracts, and therefore the items available on FSS contracts may not always be those that clinicians prefer to use based on their expertise and experience. Additionally, these officials expressed concern that an evaluation of the clinical efficacy of an item is not conducted in awarding FSS contracts. These officials further stated that VHA prefers to develop national committed-use contracts, for which a clinical efficacy evaluation is conducted. The director of a VHA clinical program that uses surgical implants further emphasized that clinician decisions on which implants to use should be based on proven clinical efficacy rather than inclusion on an FSS contract. We found that among the four VAMCs we visited: (1) none fully complied with requirements for obtaining waivers for open-market purchases of surgical implants; (2) none fully complied with additional requirements for documenting open-market purchases, which are part of VHA’s new process for surgical implant purchases over $3,000; and (3) three of the four did not comply with a requirement related to consignment agreements with surgical implant vendors. None of the four VAMCs we visited fully complied with VHA requirements for obtaining waivers for open-market purchases of surgical implants. We found that one VAMC partially complied with each requirement, while the others did not comply. Current VHA requirements applicable to the four VAMCs stipulate that all open-market purchases of non-biological implants require a waiver approved by the VAMC Chief of Staff—regardless of the purchase price—when a comparable item would have been available through a national committed-use contract, and all open-market purchases of biological implants require a waiver approved by VHA’s Procurement and Logistics Office—regardless of the purchase price—when a decision is made to purchase an item from the open market rather than from an FSS contract. On each of these waivers, VAMCs are required to document why the clinician chose not to use a surgical implant that is available on an existing, higher-priority contract—for example, because the clinician did not believe that the implant met a patient’s need or because the clinician had concerns about the quality of the items available on contract. Specifically, compliance with these waiver requirements was as follows at the four VAMCs we visited: We found that only one of the four VAMCs we visited partially complied with the waiver requirement for open-market purchases of non-biological implants, when a comparable item was available through a national committed-use contract. At this VAMC, we found that waivers were obtained for 27 of the 30 purchases we reviewed; however, 20 of the 27 waivers were incomplete, as they lacked the approving signature from the VAMC Chief of Staff.