Description
LIMITED SOURCES JUSTIFICATION FAR PART 8.405-6 2237 Transaction # or Vista Equipment Transaction #:549-13-2-4028-0068 This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer's name for material or contractor's name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: TRUVEN HEALTH ANALYTICS INC/Cox Subscription Manufacturer/Contractor POC & phone number: Debra Knox (800) 571-9554 X215 Mfgr/Contractor Address: 201 Village Road, Shallotte NC, 18470-4441 Dealer/Rep address/phone number: N/A 0 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs North Texas Veteran Health Care System 4500 S. Lancaster Rd . Dallas, TX 78216-3400 Network Contract Office 17 VISN: (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: VISN -17 intends to negotiate and award base plus 2 option year contract on a limited source basis with Cox Subscription Inc., a sole distributor of Cox Subscription Inc. . (3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: MicroMedex includes a wide range of drug information, including: AltMedDex System, AltMedDexPoints (both on alternative medicine including herbals, vitamins, minerals and other dietary supplements), ClinicalPoints, CareNotes System (7800 fully customizable patient education documents written at an appropriate level), Drugdex (drug information and interactions, including FDA approved and off-labeled uses), Identidex (pictures to allow quick identification of over 150,000 unknown tablets and capsules), PDR, the PDR of nonprescription drugs and for ophthalmic medicines, toxicology information (includes Martindale, poisindex and material safety data sheets, disease information, IV compatibility, mobile applications for both iPhone and Android, customer service 24/7, training including onsite training, pre-recorded self-paced training, and customized webinars. (b) ESTIMATED DOLLAR VALUE: Base Year: $147,106.55, 2 Option Year Total: $454,691.63 (c) REQUIRED DELIVERY DATE: Projected start date is 1 April 2013 thru 31 March 2014 with two (2) Option years extending service until 31 March 2016. (4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE) 1 Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources: The uniquely developed software developed by TRUVEN HEALTH ANALYTICS INC allows clinicians and medical staff rapid and consistent searching throughout all portions of the Computerized Clinical Information System (CCIS). Extremely user-friendly, the copywriter, proprietary access software makes using CCIS so inviting, even novice users can easily retrieve data with minimal oversight. The access software is only available exclusively from TRUVEN HEALTH ANALYTICS INC and one (1) SDVOSB authorized distributor. MICROMEDEX provides more detailed information in all categories/topics including the references for the majority of details they print. This is extremely helpful when pharmacists are required to provide clinical answers and recommendations that need to be indisputable to drive home a point and expedite patient care. Other brands do not provide very adequate information for the clinical staff to easily reference drug information and lack sufficient details down to the second and third tier that clinicians might need to differentiate treatment options based on published journals/studies provided by MICROMEDEX. Attached is an example from MICROMEDEX and a competitor regarding the drug, terazosin, and the topic of dosing for adults. Normal Dosage Terazosin Hydrochloride Intravenous route Oral route Intravenous route a) Intravenous doses of 1, 2, and 5 milligrams terazosin have produced significant reductions in diastolic blood pressure [68]. Oral route Benign prostatic hyperplasia Hypertension Benign prostatic hyperplasia 1) The manufacturer recommends starting all patients at a dose of 1 milligram at bedtime, and this dose should not be exceeded as an initial dose in order to minimized the risk of severe hypotension. A dose of 10 milligrams once daily for 4 to 6 weeks is usually required to achieve a clinical response; however the dose should be increased slowly to the desired response [30]. 2) Effective doses of terazosin in the treatment of BENIGN PROSTATIC HYPERTROPHY have ranged from 2 to 10 milligrams once daily [41][52][53][54][55][56]. 3) Following discontinuation of terazosin for several days, therapy should be reinstituted using the initial 1 milligram dosing schedule, with titration to a maintenance dose [30]. 4) Doxazosin-To-Terazosin Conversion a) According to 1 study, dosage-conversion from doxazosin to terazosin results in similar or better control of symptoms in most (83%) patients with BENIGN PROSTATIC HYPERPLASIA (BPH). In this study, patients with BPH (n=69) were switched from doxazosin to terazosin according to the following protocol: doxazosin 1 milligram (mg) to terazosin 1 mg, 2 mg to 2 mg, 4 mg to 5 mg, 8 mg to 10 mg, 12 mg to 15 mg, and 16 mg to 20 mg. There were no significant differences in International Prostate Symptom Score (IPSS), blood pressure, pulse, or adverse effects before and after the conversion (p less than 0.05). Following the conversion to terazosin, 60% of patients had no significant change in IPSS, 23% had significantly better control of BPH symptoms, and 17% had significantly worse control of BPH symptoms [337]. Hypertension 1) Due to the potential for a severe hypotensive episode upon initiation of dosing with terazosin, the manufacturer recommends an initial dose of 1 milligram orally at bedtime [30]. Titration of the dose to patient response is recommended with the usual dosing range reported as 1 milligram to 5 milligrams daily (morning or evening) or twice daily. Some patients may require doses of 20 milligrams daily, however higher doses do not provide further reductions in blood pressure and doses over 40 milligrams have not been studied [30][31]. 2) Following discontinuation of terazosin for several days, therapy should be reinstituted using the initial 1 milligram dosing schedule, with titration to a maintenance dose [30]. a) COMBINATION THERAPY 1) Terazosin can be used in combination with other antihypertensive agents. When adding another antihypertensive agent, the manufacturer recommends reducing the dose of terazosin and then re-titrating the dose to avoid developing significant hypotension [30]. 3) Doses of 10 milligrams orally once daily have been effective in the treatment of essential hypertension [23]. Doses of 20 milligrams once daily have also been reported effective [32]; (Dietz, 1984) and one study [33] reported the efficacy of 20 milligrams orally twice daily as single agent therapy in essential hypertension. Competitor Dosing: Adult Note: If drug is discontinued for greater than several days, consider beginning with initial dose and retitrate as needed. Hypertension: Oral: Initial: 1 mg at bedtime; slowly increase dose to achieve desired blood pressure, up to 20 mg/day; usual dose range (JNC 7): 1-20 mg once daily. Note: Dosage may be given on a twice daily regimen if response is diminished at 24 hours and hypotension is observed at 2-4 hours following a dose. Benign prostatic hyperplasia: Oral: Initial: 1 mg at bedtime; thereafter, titrate upwards, if needed, over several weeks, balancing therapeutic benefit with terazosin-induced postural hypotension; most patients require 10 mg day; if no response after 4-6 weeks of 10 mg/day, may increase to 20 mg/day As you can clearly see, the level of detailed information including references clearly favors MICROMEDEX. The pharmacists and other clinicians require this level of details in order to provide the highest standard of patient-centered health care to our Veterans. Unlike other information systems, TRUVEN HEALTH ANALYTICS INC has the distinction of maintaining a fulltime in-house editorial staff of professionals responsible for preserving the accuracy and quality of easy-to-use databases. It is also comprised of an editorial board of more than 350 leading specialist contributing to the systems peer review accuracy. Information presented in the database is thoroughly researched, evaluated and referenced based on the world's leading medical literature. Subscribers receive updated disc every 90 days insuring current status of the information. 0 A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. 0 These are "direct replacements" parts/components for existing equipment. _____N/A ______________________________________________________________________________________ 0 The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. _____N/A 0 The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. 0 An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: The anticipated costs for annual service for NTX, CTX, STX and VCB is estimated at $150,217.70. The cost to the Government for this service is determined to be fair and reasonable based on the historical pricing from PO#s VA549C20086 - $158,149.40, and VA549C10258 - $168,903.00. Prices have considerably decreased since the products were added to a GSA schedule contract. The base price for this service is $147,106.55. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: FAR Part 10 directs that market research be conducted on each acquisition appropriate to the circumstances. Market research was conducted on GSA Library under source code 76, category 760 1, Publication Media locating several vendors possessing SW media on other products, however none were known to be a third party distributor of MICROMEDEX database other than Cox Subscription. Efforts to solicit to other potential vendors having MICROMEDEX SW were limited. The depth and compilation of medical and health care information is a one of a kind system sold exclusively by the manufacturer - TRUVEN HEALTH ANALYTICS INC Health Analytics Inc and by one authorized third party vendor - Cox Subscription Inc. Considering this product is exclusively sold by TRUVEN Health Analytics and distributed by one third party SDVOSB reseller, posting of the limited source justification will be accomplished for orders exceeding the simplified acquisition threshold. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: The agreed upon price list for the VISN-17 includes services for NTX, CTX, STX and VCB. There is no known vendor in the market that possesses manufacture or distribution rights and that are so widely used by VISN 17 clinicians in patient care as the MICROMEDEX product. MICROMEDEX offers toll free numbers and technical support professionals, 24 hours a day to guide clinicians and staff with answer in SW, HW, and technology alternatives. (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: Barriers to overcome competition will not take place until the Library Services decides to systematically transition to another robust system with similar capabilities and distributed and/or sold by multiple vendors that can provide more of a competitive edge. (9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor's supervisor, fund control point official, chief of service or someone with responsibility and accountability.)