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| Statement | of | Work | | |
| Drug | Information | Source | for | MedlinePlus |
| National | Library | of | Medicine | |
| 1. | | Background | Information | | | | | | | | | | | | |
| To | assist | consumers | in | obtaining | the | information | they | need | to | make | informed | decisions | about | | |
| health | care, | the | National | Library | of | Medicine | (NLM) | has | developed | MedlinePlus | (medlineplus.gov), | | | | |
| an | easily | understandable | Web | resource | for | the | public. | MedlinePlus | contains | and | links | to | | | |
| information | from | authoritative | health | Web | sites | and | content | providers, | especially | those | from | the | | | |
| National | Institutes | of | Health. | | NLM | makes | MedlinePlus | available | to | the | public | through | a | variety | of |
| MedlinePlus‐branded | Web | sites, | Web | services, | Web | applications, | APIs, | email | and | social | media | | | | |
| communications, | XML | files | and | search | results. | | | | | | | | | | |
This Statement of Work (SOW) addresses NLM’s need to license a drug information source for MedlinePlus.
| 2. | | Objective | | | | | | | | | | | | |
| The | National | Library | of | Medicine | (NLM) | intends | to | license | drug | information | in | English | and | Spanish |
| to | assist | the | public | in | locating | information | about | prescription | and | over‐the‐counter | medications | via | | |
| MedlinePlus. | | NLM | makes | MedlinePlus | available | to | the | public | through | a | variety | of | MedlinePlus‐ | |
| branded | Web | sites, | Web | services, | Web | applications, | APIs, | email | and | social | media | communications, | | |
| XML | files | and | search | results. | | | | | | | | | | |
| 3. | | Mandatory | Content | Requirements | | | | | | | |
| 1. At | least | 1,000 | English | monographs. | | | | | | | |
| 2. Equivalent | content | in | Spanish. | | | | | | | | |
| 3. The | ability | to | identify | equivalent | English | and | Spanish | monographs. | The | vendor | must |
| describe | how | they | associate | equivalent | English | and | Spanish | monographs | within | the | data |
| provided | for | each | monograph. | | | | | | | | |
| 4. The | ability | to | toggle | between | all | English | and | Spanish | monographs | at | the | individual, |
| equivalent | monograph | level. | | | | | | | | | | |
| 5. Coverage | of | both | prescription | and | over‐the‐counter | medications. | | | | | | | |
| 6. Coverage | of | both | single | ingredient | medications | and | combination | ingredient | medications. | | | | |
| 7. Each | monograph | must | include | the | ingredient | (generic) | name | for | the | medication | that | is | used |
| in | the | United | States, | alternate | or | synonymous | medication | names, | when | applicable, | and | |
| associated | brand | names | and | brand | names | of | combination | products | used | in | the | United |
States.
| 8. A | stand‐alone | file | that | maps | all | the | relevant | RxNorm | Concept | Unique | Identifiers | (RXCUIs), | | | |
| including, | at | a | minimum, | all | relevant | Semantic | Clinical | Dose | Form | (SCDF) | RXCUIs, | to | each | | |
| monograph. | | The | file | must | include, | at | a | minimum, | the | monograph | ID, | the | English | | |
| monograph | name, | the | SCDF | RXCUI | and | the | SCDF | RXCUI | name. | | If | the | English | and | Spanish |
| monograph | IDs | are | not | identical | for | equivalent | English/Spanish | monographs, | then | the | file | | | | |
| must | also | include | both | the | English | monograph | ID | and | the | Spanish | monograph | ID | and | must | |
| indicate | the | equivalent | relationship | between | the | two. | | The | file | must | be | delivered | at | the | |
| same | time | as | the | monograph | updates, | and | the | file | must | reflect | the | most | recent | monograph | |
| content. | | RXCUI | mappings | embedded | within | each | individual | monograph | XML | file | are | also | | | |
| acceptable. | | Embedded | mappings | must | also | include, | at | a | minimum, | all | relevant | Semantic | | | |
| Clinical | Dose | Form | (SCDF) | RXCUIs | for | the | given | monograph. | | | | | | | |
| 9. We | expect | that | RXCUI | mappings | will | be | identical | for | the | equivalent | English | & | Spanish | |
| monographs. | | If | there | is | ever | a | circumstance | where | the | mapping | would | differ | between | the |
| equivalent | English | & | Spanish | monographs, | the | vendor | must | describe | this | circumstance | and | | | |
| how | they | handle | it | from | an | editorial | perspective | and | within | the | stand‐alone | mapping | file | or |
| embedded | mappings. | | | | | | | | | | | | | |
| 10. The | vendor | must | explain | their | process | of | mapping | monographs | to | RXCUIs | and | their | process |
| for | updating | and | maintaining | those | mappings. | | | | | | | | |
| 11. Permission | for | NLM | to | display | an | excerpt | of | 1‐2 | sentences, | or | “snippet”, | of | English | and | | |
| Spanish | monographs, | in | the | MedlinePlus | Connect | Web | Applications. | Snippets | would | be | | | | | | |
| followed | by | a | “Read | More” | link | pointing | to | the | full‐text | monograph | on | the | MedlinePlus | | | |
| website. | | Permission | for | NLM | to | deliver | these | snippets | in | the | XML | returned | to | users | of | the |
| MedlinePlus | Connect | Web | Services. | | | | | | | | | | | | | |
| 12. All | content | must | be | free | of | commercial | endorsements | or | advertisements. | | | | |
| 13. The | vendor | must | describe | the | typical | contents | of | each | monograph | or | each | class | of |
| monograph | if | there | are | multiple | classes | of | them. | | Contents | may | include, | but | are | not | limited |
| to, | information | on | why | a | medication | is | prescribed, | how | it | is | used, | precautions, | side | effects, | |
| interactions, | storage, | missed | doses | and | overdose | information. | | The | vendor | must | list | the | | | |
| topics | or | sections | that | they | cover | on | each | monograph | and | describe | the | contents | of | those | |
topics/sections.
| 14. The | vendor | must | describe | their | process | for | keeping | monograph | content | up | to | date. | |
| 15. The | vendor | must | describe | how | they | keep | up | with, | display, | and | make | editorial | decisions |
| about | FDA | warnings | at | the | monograph | level | for | both | English | and | Spanish | monographs. | |
| Examples | of | warnings | include, | but | are | not | limited | to, | safety | alerts, | ongoing | safety | reviews, |
| safety | communications | and | notices | of | withdrawal | from | market. | | | | | | |
16. The vendor must address whether they provide FDA approval status at the monograph level.
| 17. The | intended | audience | for | the | monographs | must | be | general | health | information | consumers | | | | | |
| in | the | United | States. | | The | vendor | must | describe | how | they | address | the | needs | of | a | U.S. |
| consumer | audience | in | their | writing | and | in | their | editorial | policies. | | | | | | | |
| 18. Monographs | must | be | written | in | consumer‐friendly | language. | | In | the | response, | the | vendor | | |
| must | indicate | the | reading | or | grade | level. | | The | vendor | must | include | the | measurement | scale |
| used | to | determine | the | reading | or | grade | level. | | | | | | | |
| 19. Spanish | monographs | must | be | in | culturally‐neutral | Spanish | appropriate | for | a | U.S. | consumer | | | |
| audience, | not | written | or | narrated | in | the | style | or | vocabulary | of | a | particular | Spanish | speaking |
| nationality. | | The | vendor | must | describe | their | translation | procedures, | including | quality | | | | |
| control | procedures. | | | | | | | | | | | | | |
| 20. The | vendor | must | deliver | updated | monograph | and | mapping | file | content | to | NLM | at | least | once |
| a | month. | | The | response | must | include | the | vendor’s | regular | update | schedule | and | a | |
| description | of | the | content | of | the | update | and | the | delivery | mechanism. | | | | |
| 21. When | NLM | identifies | major | content | issues, | NLM | will | communicate | the | issue | with | the |
| vendor. | | The | vendor | must | describe | their | procedure | and | turn‐around | time | for | content |
| updates, | including | procedures | and | timelines | for | emergency | content | updates. | | | | |
| 22. NLM | will | forward | to | the | vendor | any | feedback | received | from | users | regarding | content. | The |
| vendor | must | describe | their | procedure | for | reviewing | this | feedback, | incorporating | this | | | |
| feedback | into | their | editorial | cycle, | and | following‐up | with | NLM | on | any | action | taken. | |
| Preferred | Content | Features | (not | mandatory) | | | | | | | | | |
| 1. Within | the | stand‐alone | file | that | maps | all | the | relevant | RXCUIs | or | within | the | RXCUIs |
| embedded | in | the | individual | monograph | XML | files, | additional | RXCUI | mappings | of | the | | |
| following | term | types | may | be | included | for | each | monograph. | | Note: | SCDF | mappings | are |
| required. | | See | “Mandatory | Content | Requirements” | above. | | | | | | | |
| a) BPCK | – | Brand | Name | Pack | | | | | | | | | |
| b) BN | – | Brand | Name | | |
| c) SCDC | – | Semantic | Clinical | Drug | Component |
| d) SCD | – | Semantic | Clinical | Drug | |
| e) SBD | – | Semantic | Branded | Drug | |
| f) SBDC | – | Semantic | Branded | Drug | Component |
| g) GPCK | – | Generic | Pack | | |
| h) SBDF | – | Semantic | Branded | Drug | Form |
| 2. If | the | vendor | provides | the | RXCUI | mappings | in | a | stand‐alone | file, | the | stand‐alone | file |
| includes | the | Spanish | monograph | name | for | each | entry. | | | | | | |
| 3. A | pronunciation | guide | for | the | monograph | name | (ingredient/generic | name). | | | | | | |
| 4. Pill | images | with | meaningful | alt | text | in | both | English | and | Spanish. | The | vendor | must | provide |
| an | identifier | for | linking | the | pill | images | to | the | appropriate | English | & | Spanish | monographs. | | If |
| the | vendor | offers | pill | images, | they | must | include | at | least | 5 | sample | images | with | their | |
| proposal. | | The | vendor | must | also | describe | or | demonstrate | how | they | associate | individual | pill | | |
| image | files | to | individual | English | and | Spanish | monograph | XML | files. | | The | pill | images | must | be |
| delivered | at | the | same | time | as | the | monograph | updates, | and | the | pill | images | must | reflect | the |
| most | recent | monograph | content. | Image dimensions must be specified as well. | | | | | | | | | | | |
| 5. Citations | or | references, | with | PubMed | links, | in | each | monograph. |
| 6. Relative | links | to | other | monographs | in | the | collection. | |
| 7. Indicate | any | other | special | features | available. | | | |
| 4. | Mandatory | Technical | Requirements | | | | | | | | | |
| 1. Delivery | of | monographs | in | well‐formed, | valid | XML | format | with | an | accompanying | DTD | or |
| schema. | | A | schema | is | preferred. | | | | | | | | | | | |
| 2. Delivery | of | individual | XML | files | for | each | monograph | in | each | language | – | One | XML | file | for | the |
| English | monograph | and | a | separate | XML | file | for | the | equivalent | Spanish | monograph. | | |
| 3. Delivery | of | monograph‐to‐SCDF | RXCUI | mappings | in | a | stand‐alone | CSV | or | XML | file | (XML | is |
| preferred | but | CSV | is | acceptable) | or | embedded | within | each | individual | monograph | XML | file. | | |
| 4. Allow | NLM | to | host | all | the | vendor‐provided | content | on | NLM | servers, | including | pill | images, | if |
applicable.
| 5. Allow | for | MedlinePlus | co‐branding | on | drug | information | pages. | | | | | | |
| 6. The | awardee | will | be | required | to | provide | NLM | with | technical | support | and | advanced | delivery |
| of | the | content | files | within | 2 | weeks | of | being | selected | by | NLM | so | that | NLM | can | implement | the |
| co‐branded | content | pages | and | links | to | these | pages | on | MedlinePlus‐branded | sites, | services | | | | | | |
| and | files. | | | | | | | | | | | | | | | | |
| 7. When | NLM | identifies | major | technical | issues, | NLM | will | communicate | the | issue | with | the | |
| vendor. | | The | vendor | must | describe | their | procedure | and | turn‐around | time | for | technical | fixes, |
| including | procedures | and | timelines | for | emergency | fixes. | | | | | | | |
| 8. Accessibility | of | content: | | All | electronic | content | must | meet | Section | 508 | Guidelines. | See | the |
| more | specific | requirements | regarding | Accessibility | Compliance | below. | | | | | | | |
5.1 Accessibility Requirements
| Section | 508 | of | the | Rehabilitation | Act | requires | that | Federal | agencies' | electronic | and | information | | | |
| technology | is | accessible | to | people | with | disabilities. | | The | drug | Web | site | must | be | Section | 508 |
| compliant. | Specifically, | the | end | product | must | be | conformant | with | all | applicable | provisions, | | | | |
including:
| 1194.22 | Web‐based | intranet | and | internet | information | and | applications |
| 1194.31 | Functional | performance | criteria. | | | | |
| 1194.41 | Information, | documentation, | and | support. | | | |
Applicable clauses depend on the nature of the content. These provisions can be found at https://www.access‐board.gov/guidelines‐and‐standards/communications‐and‐it/about‐the‐ section‐508‐standards/section‐508‐standards
| The | Section | 508 | ‘Refresh’ | will | be | effective | January | 18, | 2018. | | | The | Offeror | will | be | expected | to | |
| provide | Information | and | Communications | Technology | (ICT) | that | complies | with | these | revised | | | | | | | | |
| section | 508 | standards | beginning | no | later | than | on | this | date. | | The | new | Section | 508 | standards | largely | | |
| adopt | Level | A | and | AA | conformance | to | the | World | Wide | Web | Consortium’s | Web | Accessibility | | | | | |
| Initiative | (W3C‐WAI) | WCAG | 2.0 | standards, | and | also | extend | these | web | standards | to | documents | and | | | | | |
| application | interfaces, | and | revamp | Section | 255 | Guidelines | of | the | Communications | Act | of | 1934. | | | | | | |
| Section | 508 | conformance | includes | ensuring | that | all | content, | including | text, | all | non‐text | content | | | | | |
| such | as | multimedia | and | images, | and | any | associated | players | or | viewers, | are | fully | accessible | per | | | | |
| Section | 508 | “Refresh” | and | WCAG | 2.0 | Level | A | and | AA | standards. | | This | includes | but | is | not | limited | to |
| ensuring | that | all | text | elements | are | captioned | and | synchronized | with | the | content | and | that | all | non‐ | | | |
| text | elements | are | fully | described, | including | any | images, | still | or | moving, | that | provide | context | as | to | | | |
| the | meaning | of | the | content. | | | | | | | | | | | | | | |
| 5.2 | Accessibility | Program | Need | | | | | | | | | | | |
| Requirements | for | accessibility | based | on | Section | 508 | of | the | Rehabilitation | Act | of | 1973 | (29 | U.S.C. |
| 794d) | are | determined | to | be | relevant | for | the | following | program | need: | "Drug | Information | Source | for |
MedlinePlus."
| 5.3 | Accessibility | Product | Requirements | | | | | | | | | | | | | |
| 1194.22, | 1194.31 | and | 1194.41 | from | 36 | CFR | part | 1194 | Subpart | D | have | been | determined | to | apply | to |
| this | acquisition. | Solicitation | respondents | must | describe | how | Information | and | Communication | | | | | | | |
| Technology | deliverables | meet | at | least | these | requirements | identified | as | applicable | in | the | attached | | | | |
| Government | Product/Service | Accessibility | Template | (GPAT). | | | | | | | | | | | | |
| 5.4 | Accessibility | Evaluation | Factors | | | | | | | | | | | | |
| Responses | to | this | solicitation | will | only | be | considered | for | award | after | it | has | been | determined | that |
| the | proposal | adequately | addresses | the | requirements | for | Section | 508. | | Only | proposals | which | contain | | |
| adequate | information | to | document | their | responsiveness | to | the | Section | 508 | requirements | (e.g. | a | | | |
| completed | GPAT) | will | be | eligible | for | any | additional | merit | consideration. | | | | | | |
| 5.5 | Accessibility | Acceptance | Criteria | | | | | | | | | | | | | | |
| The | drug | information | licensed | as | a | result | of | this | solicitation | will | be | accepted | based | in | part | on | |
| satisfaction | of | identified | Section | 508 | requirements | for | accessibility. | | The | drug | information | vendor | | | | | |
| must | include | a | completed | GPAT, | a | sample | of | which | is | included | as | a | part | of | this | solicitation. | The |
| Offeror | should | complete | the | two | right‐hand | columns, | including | an | explanation | of | how | the | product | | | | |
| complies | with | the | clause. | | | | | | | | | | | | | | |
| If | the | deliverable | includes | features | and | functions | in | addition | to | those | identified | as | requirements, |
| these | features | and | functions | also | need | to | conform | to | relevant | Section | 508 | technical | provisions, |
| functional | performance | criteria, | and | information, | documentation | and | support. | | | | | | |
| 6. | | Additional | Requirements | | | | | | | | | | | |
| 1. Features | and | product | offerings | will | be | evaluated | as | they | exist | at | the | time | of | proposal |
submission. Beta releases and planned updates will not be considered.
| 2. Include | the | cost | for | licensing | this | product. | The | cost | must | be | an | annual | flat | fee | for | providing |
| the | content | to | users | of | any | MedlinePlus | branded | Web | site, | the | ability | for | end‐users | of | | |
| MedlinePlus‐branded | sites | to | print, | email | and | share | links | to | the | content | for | individual, | | | | |
| personal | use, | and | for | providing | links | to | the | content | on | any | MedlinePlus | branded | Web | | | |
| service, | Web | application, | API, | email | and | social | media | communication, | XML | file | and | search | | | | |
result.
| 3. Include | a | sample | license | agreement | governing | the | use | of | the | content | on | all | MedlinePlus‐ |
| branded | Web | sites, | Web | services, | Web | applications, | APIs, | email | and | social | media | | |
| communications, | XML | files | and | search | results. | | The | license | agreement | must | also | address | |
| NLM’s | rights | related | to | the | sharing | of | links | to | the | content | on | MedlinePlus‐branded | sites, |
| services, | applications, | communications, | files | and | search | results. | | | | | | | |
| 4. Include | your | copyright | statement | and | any | required | disclaimers | in | both | English | and | Spanish. | | |
| 5. If | the | vendor | requires | their | logo | to | be | displayed | on | all | vendor‐supplied | content | pages, | the |
| logo | must | be | smaller | than | 70x70 | pixels | and | NLM | must | be | allowed | to | determine | the | | | |
| placement | of | the | logo | on | the | content | pages. | | Include | a | sample | of | the | logo | (in | English | and |
| Spanish | if | the | logo | differs | in | each | language) | and | any | display | requirements. | | | | | | |
| 6. Provide | a | list | of | at | least | three | other | organizations | that | license | the | content, | along | with |
| accompanying | Web | site | URLs. | | Provide | at | least | three | references | that | NLM | can | contact. | |
| 7. Provide | a | copy | of | your | customer | service | policy, | or | other | evidence | of | your | commitment | to |
| customer | service. | | | | | | | | | | | | | |
| 8. Provide | a | copy | of | your | editorial | policies | and | procedures. | | Also | include | the | names | and |
| affiliations | of | the | members | of | your | editorial | and/or | medical | board. | | | | | |
| 9. The | vendor | must | have | policies/procedures | in | place | regarding | the | quality | control | of | the |
| drug | information | and | associated | RXCUI | mapping | file. | | Provide | these | policies/procedures | in | |
| your | response. | | | | | | | | | | | |
| 10. Include | 5 | English | monographs | and | their | Spanish | equivalents | in | both | XML | format | and | an |
| example | of | the | final | presentation | format. | | | | | | | | |
| 11. Include | your | schema | (preferred) | or | DTD. | | | | | | | |
| 12. Include | a | sample | of | the | stand‐alone | monograph‐to‐RXCUI | mapping | file | that | covers | at | least |
| 10% | of | the | entire | monograph | collection | being | offered, | including | the | 5 | example | monographs | | | |
| required | in | #8 | above. | | If | the | RXCUI | mappings | will | be | embedded | in | the | monograph | XML, |
| provide | those | embedded | mappings | in | the | 5 | example | monographs | required | in | #8 | above. | | | |
7. Place of Performance
Files will be delivered or retrieved electronically.
8. Deliverables/Delivery Schedule
SOW TASK # Deliverable Title #Calendar Days After Award
15 Initial content file delivery 14 days after award
3 Content update At a mutually agreeable schedule
| | 3 | Response | to | requests | for | emergency | updating |
| of | content | | | | | | | |
| Within | a | mutually | agreeable |
| turn‐around | time | | |
| 9. | Inspection | and | Acceptance | Criteria | | | | | | | | | | | | | |
| NLM | will | inspect | and | do | a | quality | review | of | the | delivered | content | as | part | of | the | regular | update |
process.
| 10. | Other | Pertinent | Information | or | Special | Considerations | | | | | | | | | |
| Features | and | product | offerings | will | be | evaluated | as | they | exist | at | the | time | of | proposal | submission. |
| Beta | releases | and | planned | updates | will | not | be | considered. | | | | | | | |
| 11. | Transition | Plan | | | | | | | | | | | | | | | |
| The | awardee | will | be | required | to | provide | NLM | with | technical | support | and | advanced | delivery | of | the | | |
| content | files | within | 14 | days | of | being | selected | by | NLM | so | that | NLM | can | plan | for | the | implementation |
| of | the | content | pages | and | links | to | these | pages | on | MedlinePlus‐branded | sites, | services | and | files. | | | |
| In | the | event | that | NLM | ceases | licensing | this | product, | the | Offeror | will | be | notified | within | 30 | calendar |
| days | of | the | change, | but | will | help | assist | with | the | transition | by | providing | technical | support | and | |
| addressing | questions | that | facilitate | transitioning | to | a | new | provider | of | content. | The | contractor | shall | | | |
| create | any | requested | non‐proprietary | documentation | that | NLM | requests | to | aid | with | the | transition. | | | | |
| Any | documentation | developed | for | this | purpose | shall | be | the | property | of | the | government. | | | | |