Attachment 1 - Requirement Doc - First Data Bank - for SAM.gov.docx

Requirements Document For First Databank Drug Information and Pricing Database and Decision Support Tools and Renewal Services Indian Health Service

BACKGROUND: The Indian Health Service (IHS) has a mission to raise the physical, mental, social and spiritual health of American Indians and Alaska natives (AI/AN) to the highest level. To support IHS mission, Office of Information Technology (OIT) provides monthly drug information and drug pricing updates to Resource Patient Management System (RPMS) by monthly PRMS patch releases to sites across IHS. These updates are used to maintain up-to-date automated clinical decision support ordering checks for drug allergies and drug interactions and drug pricing update for billing and revenue generation.

For many years, IHS has been using MedKnowledge, a brand name Commercial Off the Shelf (COTS) database from First Databank, Inc. (FDB), which provides for clinical decision support software used in the IHS RPMS Electronic Health Record (RPMS-HER) system, as well as the RPMS pharmacy packages. These clinical decision supports tools are required for medication order checks such as drug-drug interactions, drug allergy, duplicate therapy, and dosing. These order checks are vital to the mission of IHS and will place patients at significant risk if they are not available. This database is also required for inventory control, claims adjudication, market research for contracting, and used to validate internal IHS data such as National Drug Code (NDC) and pricing information.

Currently IHS relies upon the Veterans Health Administration’s Pharmacy Product System National (PPS-N) PPS-N and National Drug File updates to update RPMS drug database information. PPS-N is a VA developed system that is used to manage updates to the local copies of the National Drug File (NDF). These updates occur monthly. The PPS-N/NDF system has been used since 1987 as a way to tie local drug files to a national standard. MedKnowledge is linked to the VA PPS-N/NDF system and allows VA to utilize both VA and MedKnowledge database information in a coordinated and seamless process. IHS receives these NDF updates from VA and incorporates the updates directly into RPMS NDF updates unchanged. Examples of this include NDC information, Patient Medication Information (PMI) and auxiliary warning labels. PPS- N/NDF also coordinates with the Medication Order Check Healthcare Application (MOCHA) to complete order checks on each prescription as part of the ordering process

OBJECTIVE

The objective of this acquisition is for the renewal of the existing brand name First Databank Inc. MedKnowledge products which provide continuous support required for the IHS.

SCOPE: This acquisition provides the drug information and pricing database from FDB for clinical decision support software used in RPMS HER, as well as the pharmacy packages. These clinical decision support tools are required for medication order checks including: drug-drug interactions, duplicate therapy, and drug allergies. The database is also required for drug pricing, claims adjudication, and billing.

REQUIREMENTS: The contractor shall provide the renewal of the existing brand name FDB MedKnowledge product requirements identified in the following:

FDB MedKnowledge Product Description:

FDB MedKnowledge Enhanced FDB MedKnowledge Framework FDB Spanish Language Bundle

1.) General Requirements:

a. Enterprise wide. All data must be available IHS wide. In addition, any non-proprietary information may also be shared with users outside the IHS (example, non-IHS RPMS users) and be used to prepare reports needed within the IHS.

b. If the Contractor is not the originator of the source file data, a copy of the signed agreement between the Contractor and the manufacturer must be submitted with the proposal. The agreement must be for a maximum term of the contract. If this agreement is not provided, the contractor will be considered non-compliant and removed from consideration.

c. Files must be updated at least as frequently as weekly. The mechanism that updates to the drug data are distributed must be done via SFTP and via VA NDF patch updates. The Contractor must supply manuals and documentation when requested.

d. The IHS reserves the right to all upgrades and enhancements at no additional fee.

2.) Drug File Database requirements:

The drug file database must have the following minimum requirements for the drug file as specified below:

a. NDC, or other unique identifier such as UPC, UPN.

b. Manufacturer

c. Route of administration

d. Package size, package type

e. Inactivation data

f. Old NDC

g. Dosage form

h. Strength, units

i. Dispense unit

j. Generic name

k. Controlled substance schedule

l. Orange Book Code

m. Classification system

n. New items indicator

o. Updated wholesale prices. The database should also contain historical information on pricing including but not limited to: average wholesale prices, wholesale acquisition cost.

The database shall include both active and inactive items. Items must be actively reviewed and updated at least weekly.

The Contractor is also responsible for matching their database to the VA NDF database. If products cannot be matched they must be checked to determine if they are inactive.

The Contractor must also develop a system for requests for updates to their system. The system will enable IHS personnel or other vendors a system to request additions to the Contractor’s database.

3.) Patient Medication Information:

The Patient Medication Information Records (PMI) for medications. The minimum requirements for the PMI for each medication included in the database are specified below:

a. The PMI database must contain the following information:

· Medical Condition for which the medication is used.

· Potential drug interactions

· Proper use of medication (e.g. “take with food”)

· Possible side effects with distinction between those that may, or may not require medical attention.

· Proper storage recommendations.

· Phonetic Pronunciation

b. The PMI shall include both the generic and trade names associated with the medication.

c. The PMI shall provide medication information in both English and Spanish text.

d. The source file must be in a relational database format. Each section must be broken down into its individual components. Each component must be indexed for data manipulation.

e. A multi-disciplinary editorial staff, consisting of pharmacists, physicians, nurses and dietitians when appropriate shall develop the medication information provided in the PMI database.

f. PMI shall meet the requirements of the Omnibus Budget Reconciliation Act (OBRA) of 1990. In addition, it must meet all requirements of the Keystone Agreements.

Vendors must supply a list of all PMI monographs as well as a total number of monographs titles.

4.) Drug-Drug Interaction:

The minimum requirements for the drug-drug interaction database included are specified below:

a. Drug-Drug Interactions must include a trigger for order checks on all new and active orders, including prescription, OTC and herbal products at the drug ingredient (multiple) and drug class (multiple) level, where appropriate.

b. The Contractor system must rank interactions in order of clinical significance and severity.

c. The Contractor system must screen by route of administration.

d. The Contractor system must include a short description of the interaction.

e. The Contractor system must include a professional description of the interaction including recommendations for action and references.

f. The Contractor system must allow customization to site-specific clinical practices.

5.) Drug-Disease:

The minimum requirements for the drug-disease database are specified below:

a. Drug-disease contraindications must include a trigger for order checks on all new and active orders, including OTC and herbal products at the drug ingredient (multiple) and Drug Class (multiple) level, where appropriate and a disease state or medical condition for a specific patient based on an ICD-10 code or SNOMED CT (preferred) inferred by proxy based on the patient's current medication profile.

b. The Contractor system must include a short description of the interaction, severity and plausibility of the contraindication.

c. The Contractor system must screen by route of administration.

d. The Contractor system must allow customization so that individual sites can better manage or alert providers of appropriate therapy.

The Contractor system may also include:

The ability to generate an alert based on other patient parameters, such as age, gender, smoking habits or alcohol use.

6.) Drug Dosing:

The minimum requirements for the drug dosing are specified below:

a. Drug dosing must provide information on minimum, maximum and usual daily doses based on patient-specific parameters such as age, height, weight, renal function, hepatic function, indication and other parameters as deemed appropriate for the drug and route of administration.

b. The Contractor system must provide information on the frequency of dosing maximum single, and maximum daily.

c. The Contractor system must provide information on the minimum, usual and maximum duration of therapy based on patient-specific parameters.

d. The Contractor system must provide some type of warning that a dose must be modified due to patient-specific parameters.

e. The Contractor system must handle non-numeric, multiple ingredient or % products.

f. The Contractor system must allow customization to site-specific clinical practices.

7.) Drug Indication:

The minimum requirements for the drug-indication database are specified below:

a. Drug indication must provide information on the appropriate therapeutic agents and alternatives, both labelled and unlabeled, for a given indication based on ICD-10 codes or SNOMED CT.

b. The Contractor system must also provide an indication of the probability (plausibility) that a drug product will be used to treat the indication.

c. IHS reserves the right to match to any other outside indication source.

8.) Warning Labels:

The minimum requirements for the warning label database are specified below:

a. A comprehensive text file of warning labels must be supplied.

b. Warning labels must be matched to individual products.

c. For each product the warning labels must be prioritized in order of importance.

9.) Pregnancy-Lactation Warnings:

The minimum requirements for the warning label database are specified below:

a. Pregnancy and lactation information should be displayed for each product.

b. Pregnancy and lactation warnings must alert and the time or order entry. For pregnancy alerts it must display FDA established categories to indicate a drug's potential for causing teratogenicity. For lactation the alert must display whether it is safe, unsafe or unknown for breast-feeding.

c. All information should be referenced.

10.) Duplicate-Therapy:

The minimum requirements for the duplicate-therapy database are specified below:

a. Duplicates should be identified at the generic drug level or any of the other levels of a multi-level (will be rated good) or variable-level (will be rated better) drug classification hierarchy.

b. Includes checks for duplicates within controlled substances, legend Rx drugs, OTCs, and herbals.

c. The Contractor system must allow customization to site-specific clinical practices.

The Contractor system may also include:

The ability to control duplicate therapy alerts using numeric thresholds by product class.

11.) Drug-Allergy:

The minimum requirements for the duplicate-allergy database are specified below:

a. Drug-Allergy, include a trigger for order checks on the following

· DRUG INGREDIENTS (multiple)

· DRUG CLASSES (multiple).

b. The Contractor system must include a monograph. The monograph must include recommendations for alternative therapy if applicable, allergy symptoms and/or adverse reactions.

d. All monographs must be referenced.

e. The Contractor system must have classifications of clinical relevance, similar to Severity: Minor, Significant, Severe

Attachment 1

12.) Referential Resources The minimum requirements for the referential resources specified below.

· Chemical description of the product.

· Therapeutic class information.

· Indications

· Patient dosing, normal as well as age and disease specific.

· How supplied, including trade names.

· Clinical monitoring

· Adverse events such as interactions, precautions, pregnancy information.

· Contraindications

The Contractor system may also include:

The ability to look up and review information based on the National Drug Code (NDC).

Vendor shall provide all software, updates or fixes as soon as made available.

DELIVERY:

Electronic Delivery to:

US Department of Health and Human Services Indian Health Service, Office of Information Technology Attn: Sadra Kasraian – Division of Information Technology (DIT) Email suryam.palanki@ihs.gov Phone: (240)535-7890

PERIOD OF PERFORMANCE or DELIVERY DATE:

SECURITY:

508 COMPLIANCE

Section 508 of the Rehabilitation Act of 1973 (found at 29 USC 794d) requires access to and use of information by individuals with disabilities. Electronic reports, video footage, and other electronic data are subject to Section 508 guidelines. The NASA SEWP IDIQ will be used to obtain the products included in this requirement. All IT products available from NASA SEWP comply with the applicable accessibility standards at 36 CFR 1194, which implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.section508.gov include any security information – (Entry to Federal buildings or access to systems, personnel clearances, computer security, 508 compliance, IPv6, etc.).

Standards applicable to this acquisition include:

X Software Applications and Operating Systems 1194.21 ___ Web-based Intranet and Internet Information and Applications 1194.22 X_ Telecommunications Products 1194.23 ___ Video or Multimedia Products 1194.24 ___ Self-Contained, Closed Products 1194.25 ___ Functional performance criteria 1194.31 ___ Information, Documentation, and Support 1194.41

The full text of the above referenced standards can be found at: http://www.section508.gov.

INTERNET PROTOCOL

(a) Any system hardware, software, firmware and/or networked component (voice, video or data) developed, procured, or acquired in support and/or performance of this contract shall be capable of transmitting, receiving, processing, forwarding and storing digital information across system boundaries utilizing system packets that are formatted in accordance with commercial standards of Internet Protocol (IP) version 6 (IPv6) as set forth in the USGv6 Profile (NIST Special Publication 500-267) and corresponding declarations of conformance defined in the USGv6 Test Program. In addition, this system shall maintain interoperability with lPv4 systems and provide at least the same level of performance and reliability capabilities of [Pv4 products.

(b) Specifically, any new IP product or system developed, acquired, or produced must:

(1) lnteroperate with both lPv6 and IPv4 systems and products, and

(2) Have available contractor/vendor IPv6 technical support for development and implementation and fielded product management.

(c) As IPv6 evolves, the Contractor commits to upgrading or providing an appropriate migration path for each item developed, delivered or utilized at no additional cost to ·the Government. The Contractor shall retrofit all non-IPv6 capable equipment, as defined above, that is fielded under this contract with IPv6 capable equipment, at no additional cost to the Government.

(d) The contractor shall provide technical support for both IPv4 and IPv6.

(e) Any system or software must be able to operate on networks supporting IPv4, lPv6 or one that supports both.

(f) Any product whose non-compliance is discovered and made known to the Contractor within one year after acceptance shall be upgraded, modified or replaced to bring it into compliance at no additional cost to the Government.

PREVENTION OF MALICIOUS CODE

(a) Definitions

Malicious code is a computer code developed for the purpose of causing some form of intentional damage to computer systems or networks. Malicious code may be a complete program or code imbedded in software programs that appear to provide useful functions. The term includes computer viruses and other destructive programs, such as "Trojan Horses" and network "worms."

(b) The contractor must have in place an anti-virus procedure to ensure that media supplied is uncontaminated by malicious code.

(c) The contractor is required to scan all delivered software to insure it is free of malicious code prior to its installation or operation on Government-owned computers or contractor-owned computers connected to Government computer systems or networks. Contractors using diagnostics software disks or connecting to a non-Government computer while performing repairs or upgrades to a Government computer will scan the serviced computer's drive(s) to insure they are free of malicious code upon completion of the service call, or prior to return of serviced equipment, if servicing is performed off-site.