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1 | ATTACHMENT B - RxSU2 REQUIREME NTS | |||||
2 | ||||||
3 | ||||||
4 | ||||||
5 | CONTENTS: | |||||
6 | Build 1: P harmacy Op erational UpdatesPag e 2 oRTM f or NSR 201 51007Page 3 | |||||
7 | Build 2: H azardous P harmaceuti cals Enhan cementsPag e 9 oHazar dous Drugs – Enhance ment to ND F BRDPage 10 oRTM fo r NSR 2013 0302Page 3 6 | |||||
8 | Build 3: P rescriptio n Expirati on Update Modificati on Pa ge 39 o RTM for NSR 20 150309 Req uirementsP age 40 | |||||
9 | Build 4: P harmacy Rx Verificat ion before Dispensin g Pa ge 42 o RTM for NSR 20 110415 Req uirementsP age 43 o NSR 20110415 Process Di agramPage 44 | |||||
10 | Build 5: S eparate CS /Non-CS Lo cal Parame tersPage45 o NSR 20140 108 Requir ementsPage 46 | |||||
11 | oNSR 20140 108 Proces s DiagramP age 47 | |||||
12 | Build 6: I ndividual PSPOs & Re move Clini c OptionPa ge 48 o Pati ent Safety IssuesPag e 49 o Remov e Clinic O ption from CPRS Requ irement Page 5 0 | |||||
13 | ||||||
14 | ||||||
15 | ||||||
16 | ||||||
17 | ||||||
18 | ||||||
19 | ||||||
20 | ||||||
21 | ||||||
22 | ||||||
23 | ||||||
24 | ||||||
25 | BUILD 1: P harmacy Op erational Updates | |||||
26 | ||||||
27 | ||||||
28 | ||||||
29 | ||||||
30 | ||||||
31 | ||||||
32 | ||||||
33 | ||||||
34 | ||||||
35 | ||||||
36 | ||||||
37 | Requiremen ts Traceab ility Matr ix for NSR 20151007 (Pharmacy Operationa l Updates FY16) | |||||
38 | ||||||
39 | ||||||
40 | ProPath Do c Mapping | |||||
41 | Business R equirement s Document (BRD) - B usiness Ne eds or Epi cs | |||||
42 | Optional/R equired | |||||
43 | Required | |||||
44 | Required | |||||
45 | Required ( As Applica ble) | |||||
46 | Required ( As Applica ble) | |||||
47 | Required ( As Applica ble) | |||||
48 | New Servic e Request (NSR)# | |||||
49 | Bus Req (B N or Epic) ID (Uniqu e Reposito ry Identif ier) | |||||
50 | Business R eq (BN or Epic) Summ ary | |||||
51 | User Narra tive | |||||
52 | (High leve l business requireme nt) (BRD) (Optional) | |||||
53 | Comment | |||||
54 | Mapping to Business Function F ramework | |||||
55 | (BRD) | |||||
56 | 20151007 | |||||
57 | 648304 | |||||
58 | As a provi der, I nee d to be ab le to use the renewa l function for medic ations tha t cannot b e automati cally rene wed via Au dioCare, s o that the patient r eceives th eir medica tions in a | |||||
59 | timely man ner | |||||
60 | ||||||
61 | ||||||
62 | Provide Ph armacy Ser vices (4.8 .6) | |||||
63 | 20151007 | |||||
64 | 647969 | |||||
65 | ||||||
66 | As a pharm acist, I n eed the sy stem to do cument the concept o f medicati on that ha ve been de signated a s AudioCar e-Non- Ren ewable in the Drug E nforcement Administr ation (DEA ), SPECIAL HANDLING field, so that this informatio n is offic ially reco gnized as standardiz ed and the help text acknowled ges letter “K” as th e special handling p roperty. | |||||
67 | This will enable pro viders to use the Co mputerized Patient R ecord Syst em/Veteran s Health I nformation Systems a nd Technol ogy Archit ecture (CP RS/VistA) RENEWAL fu nction whi le enablin g the pati ent to “RE QUEST” med ications t hat cannot be (autom atically) renewed vi a Audio RE NEWAL. | |||||
68 | ||||||
69 | 20151007 | |||||
70 | 647971 | |||||
71 | As a clini cian, I ne ed to be a ble to acc urately do cument the way a pat ient is ta king non-D epartment of Veteran s Affairs (VA) medic ations, so that the actual SIG (instruct ions for u se) can be captured in the med ication pr ofile. | |||||
72 | ||||||
73 | A primary example is a patient that take s 2 capsul es in the morning an d 1 capsul e in the e vening. T hat level of detail cannot be captured i n the as-i s Non-Depa rtment of Veterans A ffairs (VA ) medicati ons functi onality. This topic also rela tes to the outbound ePrescribi ng project . | |||||
74 | Provide Ph armacy Ser vices (4.8 .6) | |||||
75 | 20151007 | |||||
76 | 648305 | |||||
77 | As a clini cian, I ne ed a mecha nism to al ert me whi le writing renewal p rescriptio ns, so tha t I only r eceive the required alerts. | |||||
78 | ||||||
79 | ||||||
80 | Provide Ph armacy Ser vices (4.8 .6) | |||||
81 | 20151007 | |||||
82 | 647972 | |||||
83 | ||||||
84 | As a clini cian, I wa nt the sys tem to sup press (nui sance) dup licate- me dication a lerts when the presc ription is being wri tten withi n the last 25% of it s calculat ed days’ s upply and when the p revious pr escription was writt en by me, so that I am not re minded abo ut the fac t that I a m renewing the medic ation with in a natur ally expec ted time f rame. | |||||
85 | For discus sion, ther e are two criteria h ere – time frame and provider matching. Consider whether bo th are nec essary. | |||||
86 | ||||||
87 | 20151007 | |||||
88 | 648306 | |||||
89 | As a pharm acist, I n eed to be notified o f disconti ued orders , so that I can prev ent the wa ste of med ications. | |||||
90 | ||||||
91 | ||||||
92 | Provide Ph armacy Ser vices (4.8 .6) | |||||
93 | ||||||
94 | ||||||
95 | 20151007 | |||||
96 | 647973 | |||||
97 | As a pharm acist usin g the (to- be) ‘Disco ntinue Int ravenous (IV) Order ’ function ality, I n eed the no tice of a newly disc ontinued order to b e delivera ble to an electronic location (e.g., bin go board, smart devi ce, etc.), so that I can recei ve this in formation in an IV r oom settin g without the need t o bring pa per into a USP 797 c ertified c lean room. | |||||
98 | This is an enhanceme nt to VIP C3>C1 NSR 20141208. This will prevent w astage of expensive medication s. | |||||
99 | Data sourc e for this will be t he PBM Ext ract, once fixed to correctly collect ca nceled/rec ycled/dest royed IVs. | |||||
100 | 20151007 | |||||
101 | 648307 | |||||
102 | As a pharm acist, I n eed a mech anism to a lert me wh en there i s an ingre dient-leve l reactant to a drug , so that providers receive th e expected alerts. | |||||
103 | Provide Ph armacy Ser vices (4.8 .6) | |||||
104 | 20151007 | |||||
105 | 647974 | |||||
106 | As a pharm acist usin g the (to- be) ‘Send Mail Messa ge when De partment o f Veterans Affairs ( VA) Drug C lass field is empty’ functiona lity, I ne ed the sys tem to rec ognize all ergy react ant types that are a lways appr opriately recorded a s INGREDIE NTS (e.g., food alle rgies, lat ex), so th at it supp resses a n uisance al ert that w ill never action. | |||||
107 | Specific r ecommendat ion is to only repor t on react ants that have a dru g (D). Th is is an e nhancement to VIP C3 >C1 patch GMRA*4*50 from NSR 2 0140712. | |||||
108 | 20151007 | |||||
109 | 648311 | |||||
110 | As a pharm acisit fin ishing med ication or ders, I ne ed to be a ble to see all the d etails/inf ormation r egarding t he medicat ion and pr escriber, so that I appropriat ely fill t he order. | |||||
111 | Provide Ph armacy Ser vices (4.8 .6) | |||||
112 | 20151007 | |||||
113 | 647975 | |||||
114 | As a pharm acist fini shing medi cation ord ers, I ne ed the sys tem to pro vide two " hidden act ions" to g et more de tail about the provi der and th e medicati on on the order, so that I can confirm t he privile ges of the prescribe r for the given medi cation. | |||||
115 | Detail of hidden act ion #1 (VP ) View Pro vider ... allows the user to s ee data fr om NEW PER SON file 2 00 includi ng REMARKS , TITLE, a nd other i dentifiers . (full l ist TBD) | |||||
116 | Detail of hidden act ion #2 (DM ) Drug Mes sage...all ows the us er to see details si milar to t he standal one PSS al lows the u ser to see details s imilar to the standa lone PSS L OOK option 'Lookup i nto Dispen se Drug Fi le', field s like dru g MESSAGE, QUANTITY DISPENSE M ESSAGE, DR UG TEXT, e tc. | |||||
117 | Both hidde n actions would defu lt to the the curren t provider and curre nt drug on the order for the c ontext of what entri es to disp lay, while allowing the user t o select a lternative enteries for lookup (provicer and/or dr ug). | |||||
118 | ||||||
119 | ||||||
120 | 20151007 | |||||
121 | 648317 | |||||
122 | As a pharm acist, I n eed to be able to vi ew the sta tus of eac h entry, s o that I c an easily screen for their ava ilability. | |||||
123 | Provide Ph armacy Ser vices (4.8 .6) | |||||
124 | 20151007 | |||||
125 | 647976 | |||||
126 | As a pharm acist, I n eed the sy stem to sh ow me when entries a re inactiv e as part of a looku p list, so that I do not need to select the entry just to fi nd out tha t level of informati on. | |||||
127 | #1. This c ould be do ne by maki ng the ina ctive stat us or inac tive date an IDENTIF IER on the selected file[s]. | |||||
128 | #2 Places for this e nhancement include [ a] Lookup into Natio nal Drug F ile, [b] S tandard Sc hedules - file 51.1, [c] Drug Text Enter /Edit. | |||||
129 | 20151007 | |||||
130 | 648327 | |||||
131 | As a pharm acist, I n eed to be able to vi ew the tre ating prov ider infor mation, so I know mo re about t he acuity of the pat ient's tre atment | |||||
132 | Provide Ph armacy Ser vices (4.8 .6) | |||||
133 | 20151007 | |||||
134 | 647977 | |||||
135 | As a pharm acist, I n eed additi onal infor mation abo ut the tre ating spec ialty and attending provider o n the inpa tient medi cation 'Pa tient Info rmation' a nd 'Order Entry' scr een, so th at I know more about the acuit y of the p atient's t reatment. | |||||
136 | ||||||
137 | ||||||
138 | 560892 | |||||
139 | As a user of applica tions and systems th at transmi t health i nformation in an ele ctronic fo rm, I need to prote ct individ uals’ elec tronic Per sonal Heal th Informa tion that is created , received , used, or maintaine d by a cov ered entit y in order to comply with the Health Ins urance Por tability a nd Account ability Ac t Security Rule requ irements. | |||||
140 | ||||||
141 | ||||||
142 | 411316 | |||||
143 | 164.308 (a )(1)(ii)(B ).1 | |||||
144 | Informatio n system s hall imple ment reaso nable and appropriat e security measures to reduce risk. | |||||
145 | ||||||
146 | ||||||
147 | 411318 | |||||
148 | 164.308 (a )(1)(ii)(B ).2 | |||||
149 | Informatio n system s hall imple ment reaso nable and appropriat e security measures to minimiz e vulnerab ilities. | |||||
150 | ||||||
151 | ||||||
152 | 411319 | |||||
153 | 164.308 (a )(4)(ii)(B ).2 | |||||
154 | Informatio n systems shall vali date a use r's right of access (authoriza tion) to e lectronic Personal H ealth Info rmation. | |||||
155 | ||||||
156 | ||||||
157 | 411320 | |||||
158 | 164.308 (a )(5)(ii)(C ).2 | |||||
159 | Informatio n system s hall monit or user lo g-in attem pts. | |||||
160 | ||||||
161 | ||||||
162 | 411334 | |||||
163 | 164.308 (a )(5)(ii)(C ).3 | |||||
164 | Informatio n system s hall notif y user of invalid lo g-in attem pts. | |||||
165 | ||||||
166 | ||||||
167 | 411332 | |||||
168 | 164.308 (a )(5)(ii)(C ).4 | |||||
169 | Informatio n systems shall enfo rce a limi t to the n umber of c onsecutive invalid u ser log-in attempts during a s pecified t ime period . | |||||
170 | ||||||
171 | ||||||
172 | ||||||
173 | ||||||
174 | 411330 | |||||
175 | 164.308 (a )(5)(ii)(C ).5 | |||||
176 | ||||||
177 | Informatio n systems shall log user log-i n attempts . | |||||
178 | ||||||
179 | ||||||
180 | ||||||
181 | 411336 | |||||
182 | 164.308 (a )(5)(ii)(D ).1 | |||||
183 | ||||||
184 | Informatio n system s hall provi de capabil ity to cre ate passwo rds. | |||||
185 | ||||||
186 | ||||||
187 | ||||||
188 | 411322 | |||||
189 | 164.308 (a )(5)(ii)(D ).2 | |||||
190 | ||||||
191 | Informatio n system s hall provi de capabil ity to cha nge passwo rds. | |||||
192 | ||||||
193 | ||||||
194 | ||||||
195 | 411325 | |||||
196 | 164.308 (a )(5)(ii)(D ).3 | |||||
197 | ||||||
198 | Informatio n system s hall safeg uard passw ords. | |||||
199 | ||||||
200 | ||||||
201 | ||||||
202 | 411323 | |||||
203 | 164.312 (a )(1).1 | |||||
204 | ||||||
205 | Informatio n system s hall imple ment an el ectronic m echanism t hat allows only auth orized ent ities acce ss to elec tronic Per sonal Heal th Informa tion. | |||||
206 | ||||||
207 | ||||||
208 | ||||||
209 | 411321 | |||||
210 | 164.312 (a )(2)(i).1 | |||||
211 | ||||||
212 | Informatio n system s hall assig n a unique name and/ or number to identif y a user. | |||||
213 | ||||||
214 | ||||||
215 | ||||||
216 | 411337 | |||||
217 | 164.312 (a )(2)(i).2 | |||||
218 | ||||||
219 | Informatio n system s hall use a unique na me and/or number to track a us er. | |||||
220 | ||||||
221 | ||||||
222 | ||||||
223 | 411339 | |||||
224 | 164.312 (a )(2)(ii).2 | |||||
225 | ||||||
226 | Informatio n system s hall imple ment a pro cess to al low access to necess ary electr onic Perso nal Health Informati on during an emergen cy. | |||||
227 | ||||||
228 | ||||||
229 | ||||||
230 | 411333 | |||||
231 | 164.312 | |||||
232 | (a)(2)(iii ).1 | |||||
233 | ||||||
234 | Informatio n system s hall imple ment elect ronic mech anism to t erminate a n electron ic session after a p redetermin ed time of inactivit y. | |||||
235 | ||||||
236 | ||||||
237 | ||||||
238 | 411326 | |||||
239 | 164.312 (a )(2)(iv).1 | |||||
240 | ||||||
241 | Informatio n system s hall imple ment mecha nism to en crypt and decrypt el ectronic P ersonal He alth Infor mation. | |||||
242 | ||||||
243 | ||||||
244 | ||||||
245 | 411327 | |||||
246 | 164.312 (b ).1 | |||||
247 | ||||||
248 | Informatio n system s hall recor d activity in inform ation syst ems that c ontain or use electr onic Perso nal Health Informati on. | |||||
249 | ||||||
250 | ||||||
251 | ||||||
252 | 411324 | |||||
253 | 164.312 (b ).2 | |||||
254 | ||||||
255 | Informatio n system s hall exami ne activit y in infor mation sys tems that contain or use elect ronic Pers onal Healt h Informat ion. | |||||
256 | ||||||
257 | ||||||
258 | ||||||
259 | 411338 | |||||
260 | 164.312 (c )(1).1 | |||||
261 | ||||||
262 | Informatio n system s hall imple ment an el ectronic m echanism t o protect electronic Personal Health Inf ormation f rom improp er alterat ion. | |||||
263 | ||||||
264 | ||||||
265 | ||||||
266 | 411335 | |||||
267 | 164.312 (c )(1).2 | |||||
268 | ||||||
269 | Informatio n system s hall imple ment an el ectronic m echanism t o protect electronic Personal Health Inf ormation f rom improp er destruc tion. | |||||
270 | ||||||
271 | ||||||
272 | ||||||
273 | 411331 | |||||
274 | 164.312 (c )(2).1 | |||||
275 | ||||||
276 | Informatio n system s hall imple ment elect ronic mech anism to v erify that electroni c Personal Health In formation has not be en altered in an una uthorized manner. | |||||
277 | ||||||
278 | ||||||
279 | ||||||
280 | 411329 | |||||
281 | 164.312 (c )(2).2 | |||||
282 | ||||||
283 | Informatio n system s hall imple ment elect ronic mech anism to v erify that electroni c Personal Health In formation has not be en destroy ed in an u nauthorize d manner. | |||||
284 | ||||||
285 | ||||||
286 | ||||||
287 | 411328 | |||||
288 | 164.312 (d ).1 | |||||
289 | ||||||
290 | Informatio n system s hall imple ment elect ronic mech anisms to authentica te a user. | |||||
291 | ||||||
292 | ||||||
293 | ||||||
294 | ||||||
295 | ||||||
296 | 411342 | |||||
297 | 164.312 (e )(1).1 | |||||
298 | ||||||
299 | Informatio n system s hall imple ment mecha nisms to g uard again st unautho rized acce ss to elec tronic Per sonal Heal th Informa tion durin g transmis sion. | |||||
300 | ||||||
301 | ||||||
302 | ||||||
303 | 411341 | |||||
304 | 164.312 (e )(2)(i).1 | |||||
305 | ||||||
306 | Informatio n system s hall imple ment mecha nisms to v erify that electroni cally tran smitted el ectronic P ersonal He alth Infor mation is not improp erly modif ied during transmiss ion. | |||||
307 | ||||||
308 | ||||||
309 | ||||||
310 | 411340 | |||||
311 | 164.312 (e )(2)(ii).1 | |||||
312 | ||||||
313 | Informatio n system s hall imple ment mecha nisms to e ncrypt ele ctronic Pe rsonal Hea lth Inform ation duri ng transmi ssion. | |||||
314 | ||||||
315 | ||||||
316 | ||||||
317 | 411344 | |||||
318 | 164.312 (d ).2 | |||||
319 | ||||||
320 | Informatio n system s hall imple ment elect ronic mech anisms to authentica te an inte rfacing sy stem or ot her entity . | |||||
321 | ||||||
322 | ||||||
323 | ||||||
324 | 411343 | |||||
325 | 164.312 (e )(2)(ii).2 | |||||
326 | ||||||
327 | Informatio n system s hall imple ment mecha nisms to e ncrypt ele ctronic Pe rsonal Hea lth Inform ation at r est on mob ile device s or remov able elect ronic medi a. | |||||
328 | ||||||
329 | ||||||
330 | ||||||
331 | ||||||
332 | ||||||
333 | ||||||
334 | ||||||
335 | ||||||
336 | ||||||
337 | ||||||
338 | ||||||
339 | ||||||
340 | ||||||
341 | ||||||
342 | ||||||
343 | ||||||
344 | ||||||
345 | ||||||
346 | BUILD 2: H azardous P harmaceuti cals Enhan cements | |||||
347 | ||||||
348 | ||||||
349 | ||||||
350 | ||||||
351 | ||||||
352 | ||||||
353 | ||||||
354 | ||||||
355 | ||||||
356 | ||||||
357 | ||||||
358 | ||||||
359 | ||||||
360 | ||||||
361 | Hazardous Drugs – En hancement to Nationa l Drug Fil e Work Eff ort #20130 302 | |||||
362 | Business R equirement s Document | |||||
363 | ||||||
364 | ||||||
365 | ||||||
366 | ||||||
367 | ||||||
368 | January 20 15 | |||||
369 | ||||||
370 | Revision H istory | |||||
371 | Note: The revision h istory cyc le begins once chang es or enha ncements a re request ed after t he Busines s Requirem ents Docum ent has be en approve d. | |||||
372 | ||||||
373 | Date | |||||
374 | Descriptio n | |||||
375 | Author | |||||
376 | 11/05/2014 | |||||
377 | Initial ve rsion | |||||
378 | Jill Schep pler | |||||
379 | 1/20/2015 | |||||
380 | Approved v ersion | |||||
381 | Michael Va lentino (1 /20/2015) | |||||
382 | Shawn Fahe rty (1/20/ 2015) | |||||
383 | ||||||
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425 | ||||||
426 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
427 | Business R equirement s Document iJanuary 2 015 | |||||
428 | ||||||
429 | Table of C ontents | |||||
430 | Purpose3 | |||||
431 | Overview3 | |||||
432 | Scope4 | |||||
433 | Customer a nd Primary Stakehold ers4 | |||||
434 | Goals/Obje ctives and Outcome M easures4 | |||||
435 | Enterprise Need/Just ification5 | |||||
436 | Patient an d Care Pro vider Safe ty5 | |||||
437 | Cost Savin gs5 | |||||
438 | Regulatory Complianc e5 | |||||
439 | Business R equirement s6 | |||||
440 | Business A ctivity (T hemes), Bu siness Nee d (Epic), Business R equirement (User Nar rative)6 | |||||
441 | User Acces s Levels6 | |||||
442 | Known Inte rfaces and Data Sour ces7 | |||||
443 | Related Pr ojects or Work Effor ts7 | |||||
444 | Service Le vel Requir ements7 | |||||
445 | Availabili ty7 | |||||
446 | Capacity & Performan ce8 | |||||
447 | Interfaces and Secur ity9 | |||||
448 | Other Cons iderations 9 | |||||
449 | Alternativ es9 | |||||
450 | Assumption s9 | |||||
451 | Dependenci es10 | |||||
452 | Constraint s10 | |||||
453 | Business R isks and M itigation1 0 | |||||
454 | Appendix A References 11 | |||||
455 | Appendix B Models12 | |||||
456 | Appendix C Stakeholde rs, Users, and Workg roups16 | |||||
457 | Stakeholde rs16 | |||||
458 | Stakeholde r Support Team (BRD Developmen t)17 | |||||
459 | Appendix D User Inter face/User Centered D esign Prin ciples18 | |||||
460 | Appendix E Technical Informatio n20 | |||||
461 | Appendix F Acronyms a nd Abbrevi ations22 | |||||
462 | Appendix G Approval S ignatures2 4 | |||||
463 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
464 | Business R equirement s Document iiJanuary 2015 | |||||
465 | ||||||
466 | Purpose | |||||
467 | The Busine ss Require ments Docu ment (BRD) is author ed by the business c ommunity f or the pur pose of ca pturing an d describi ng the bus iness need s of the c ustomer/bu siness own er identif ied within the New S ervice Req uest (NSR) #20130302 .1 The B RD provide s insight into the A S-IS and T O-BE busin ess areas, identifyi ng stakeho lders and profiling primary an d secondar y user com munities. It identi fies what capabiliti es the sta keholders and the ta rget users need and why these needs exis t, providi ng a focus ed overvie w of the r equest req uirements, constrain ts, and ot her consid erations i dentified. This docu ment is a business c ase and do es not man date a dev elopment m ethodology , however the requir ements are written u sing agile methodolo gy deliver ables. The intended audience f or this do cument is the Office of Inform ation and Technology (OI&T) to facilitat e project planning w hen the pr oject is a pproved an d funded. | |||||
468 | These requ irements a re not doc umented at a level s ufficient for develo pment. | |||||
469 | Overview | |||||
470 | This reque st from th e Veterans Health Ad ministrati on (VHA) P harmacy Be nefits Man agement (P BM) Servic es Pharmac eutical Ma nagement W orkgroup s eeks to en hance the National D rug File ( NDF) by ad ding hazar dous drug identifica tion and w aste chara cterizatio n (as defi ned by the Environme ntal Prote ction Agen cy (EPA) a s toxic, f lammable, corrosive, or other type of ha zardous wa ste) infor mation. C urrently, there is n o Informat ion Techno logy (IT) system or solution t hat Depart ment of Ve terans Aff airs (VA) pharmacist s and clin icians can access to see what medication s are haza rdous to h andle (adm inister to patients, segregate , store, s hip) and d ispose of. This req uest will provide in formation regarding the safe m anagement of hazardo us medicat ions and t he ability for users to access and view the inform ation when handling or disposi ng of haza rdous medi cations. T he enhance ment is a VHA Innova tion Progr am initiat ive, devel oped as a functional prototype , and curr ently runn ing in the Innovatio n Sandbox. | |||||
471 | Currently, VA Medica l Centers (VAMC) pay a variety of contra ctors to a nalyze med ical cente r waste an d to produ ce medicat ion charac terization reports, usually in spreadshe et form, t hat includ e informat ion regard ing the me dications that are h azardous t o handle. The infor mation pro duced in t hese repor ts is ofte n a mix of medicatio n brand na mes and ge neric name s. Given that VA is a generic -only ente rprise, th is makes t he contrac tor-produc ed spreads heets less than idea l for haza rdous medi cation han dling. Th is request provides users with the abili ty to ente r only the generic m edications used by V A pharmaci es. | |||||
472 | If facilit ies do not identify hazardous medication s accurate ly, patien ts and sta ff are at risk of be ing expose d to hazar dous drugs or hazard ous drug w aste. The resulting risk to pa tient and health car e provider safety ma y result i n enforcem ent of reg ulatory sc rutiny and violation s from org anizations such as t he Food an d Drug Adm inistratio n (FDA), t he Environ mental Pro tection Ag ency (EPA) , The Join t Commissi on, and th e Occupati onal Safet y and Heal th Adminis tration (O SHA). | |||||
473 | ||||||
474 | ||||||
475 | ||||||
476 | ||||||
477 | ||||||
478 | ||||||
479 | 1 http://URL /nsrd/Tab_ GeneralInf oView.asp? RequestID= 20130302 | |||||
480 | ||||||
481 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
482 | Business R equirement s Document 3January 2 015 | |||||
483 | ||||||
484 | Scope | |||||
485 | The scope of work fo r the Haza rdous Drug s Enhancem ent to the NDF: | |||||
486 | Provide an IT soluti on that gi ves users the abilit y to indic ate which new drugs are hazard ous when t hey are ad ded to the formulary . | |||||
487 | Provide an IT soluti on that al lows users who admin ister and dispose of hazardous drugs to view infor mation tha t will ena ble them t o follow c orrect pro cedures fo r administ ering and for dispos ing of any remaining , expired, or contam inated haz ardous med ications. | |||||
488 | Customer a nd Primary Stakehold ers | |||||
489 | Michael Va lentino, C hief Consu ltant, rep resenting PBM Patien t Care Ser vices (PCS ), is the primary st akeholder for this r equest. R eview Appe ndix C for the compl ete list o f primary and second ary stakeh olders. | |||||
490 | Goals/Obje ctives and Outcome M easures | |||||
491 | ||||||
492 | Goal/Objec tive and D esired Out come | |||||
493 | Impact/Ben efit | |||||
494 | Measuremen t | |||||
495 | Eliminate reliance o n the haza rdous wast e and haza rdous to h andle Micr osoft Exce l spreadsh eets produ ced by con tractors t o characte rize waste and repla ce with an IT soluti on that in corporates the entir e dynamic NDF to pro tect patie nts and st aff who ha ndle and d ispose of hazardous medication s | |||||
496 | Improved d isseminati on of haza rdous medi cation inf ormation w ill reduce the risk to both pa tients and care prov iders that may occur when haza rdous medi cations ar e not hand led, store d, segrega ted, packa ged, and d isposed of properly. | |||||
497 | Decreased incidences of cross- contamina tion | |||||
498 | Decreased potential employee e xposures | |||||
499 | Decreased number of times a ha zardous me dication i s not hand led, store d, segrega ted, packa ged, or di sposed of properly b ecause it was miside ntified | |||||
500 | Increased accuracy d ue to more reliable data and c onsistent safe work practices across VHA | |||||
501 | Eliminate reliance o n the haza rdous wast e and haza rdous to h andle Micr osoft Exce l spreadsh eets produ ced by con tractors a nd replace with an I T solution to improv e regulato ry complia nce | |||||
502 | Ready acce ss to haza rdous medi cation inf ormation w ill assist employees who are r esponsible for the c orrect dis posal of p artially u sed, expir ed, or con taminated hazardous medication s and haza rdous wast e residue. | |||||
503 | Reduction in penalti es incurre d by facil ities as a result of regulator y violatio ns | |||||
504 | ||||||
505 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
506 | Business R equirement s Document 4January 2 015 | |||||
507 | ||||||
508 | Enterprise Need/Just ification | |||||
509 | Patient an d Care Pro vider Safe ty | |||||
510 | The lack o f a centra lized, eas y-to-acces s source o f informat ion regard ing the sa fe handlin g of hazar dous medic ations pre sents a si gnificant safety and health ri sk to both patients and health care prov iders. De spite VA t raining an d educatio n, patient health ca re provide rs such as nurses, a re often n ot able to identify hazardous drugs from memory. Without an IT soluti on to refe rence that would war n them whe n they are to admini ster, stor e, ship, o r dispose of a poten tially haz ardous med ication, t here is ri sk to both the patie nt and hea lth care p rovider’s safety. Th is enhance ment impro ves employ ee and pat ient safet y by provi ding pharm acy and nu rsing pers onnel with a tool th at enables better de cision mak ing when h andling ha zardous ph armaceutic als and di sposing of these pha rmaceutica ls when th ey become waste. The risk of n ot followi ng prescri bed proces ses for th e handling and dispo sal of haz ardous pha rmaceutica ls represe nts possib le regulat ory scruti ny from or ganization s such as the FDA, t he EPA, th e Departme nt of Tran sportation (DOT), th e Joint Co mmission, and OSHA. | |||||
511 | Cost Savin gs | |||||
512 | At the tim e this req uest was i nitiated i n 2012, th e PBM Phar maceutical Managemen t Workgrou p reported that 18 s ites had p aid a tota l of $108, 000 for co ntractor e valuation of their d rug files. If the r emaining V AMCs conti nued with this appro ach, extra polating t he $6,000 per site c ost to all VAMCs (15 0) would r esult in V A spending a total o f $900,000 for waste character ization an nually. I f each fac ility upda ted on a y early basi s, which i s conserva tive given that new drugs are continuous ly added a nd product formulati ons change d, the fiv e year cos t for wast e characte rization w ould be $4 .5 million for infor mation tha t could be obtained nationally and unifo rmly share d via prod uction imp lementatio n of this enhancemen t. | |||||
513 | Over a fiv e year spa n from 200 6 to 2011, hazardous waste vio lations in three VIS N 15 facil ities resu lted in tw o civil se ttlements for EPA pe nalties to taling $55 1,549. Th e violatio ns were pr edominantl y waste ch aracteriza tion viola tions, suc h as failu re to prop erly ident ify, segre gate, and manage pha rmaceutica l and chem ical waste at the fa cilities. Assuming t hat all VI SNs incur a similar number of hazardous waste viol ations and resulting penalties , extrapol ating the VISN 15 ci vil settle ment cost to all 23 VISNs woul d result i n a total of $12,685 ,627 over a five yea r period o r $2,537,1 25 annuall y. | |||||
514 | Regulatory Complianc e | |||||
515 | This enhan cement imp roves comp liance wit h the Reso urce Conse rvation an d Recovery Act (RCRA ) of 1976 (40 Code o f Federal Regulation s [CFR])2 and the Cl ean Water Act (40 CF R Parts 12 2 and 403) .3 Compl iance will prevent V A facility pharmaceu tical wast e from bei ng introdu ced into s treams and soil. | |||||
516 | ||||||
517 | ||||||
518 | ||||||
519 | ||||||
520 | ||||||
521 | ||||||
522 | 2 http ://www.epa .gov/agric ulture/lrc a.html | |||||
523 | 3 htt p://www.ep a.gov/agri culture/lc wa.html | |||||
524 | ||||||
525 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
526 | Business R equirement s Document 5January 2 015 | |||||
527 | ||||||
528 | Business R equirement s | |||||
529 | Business A ctivity (T hemes), Bu siness Nee d (Epic), Business R equirement (User Nar rative) | |||||
530 | Themes, ep ics, user narratives , user sto ries, and acceptance criteria will be ca ptured in the Requir ements Tra ceability Matrix (RT M). The r equirement s table be low provid es a list of the epi cs that ar e detailed in the RT M for the Hazardous Drugs – En hancement to Nationa l Drug Fil e project. The RTM is stored as a separ ate docume nt and can be access ed via the Requireme nts Tracea bility Lin k located in the New Service R equest Dat abase: | |||||
531 | http://URL /pasdocs/t raceabilit y/20130302 _Hazardous _Drugs_Enh ancement_R TM.x lsx | |||||
532 | Hazardous Drugs – En hancement to Nationa l Drug Fil e Requirem ents Table | |||||
533 | ||||||
534 | Identifier | |||||
535 | Epic | |||||
536 | 470346 | |||||
537 | As a user, I need to view haza rdous drug identific ation and waste char acterizati on informa tion, so t hat I can safely han dle and di spose of h azardous m edications . | |||||
538 | 475255 | |||||
539 | As a user, I need th e ability to indicat e which ne w drugs ar e identifi ed as haza rdous when they are added to t he formula ry, so tha t the info rmation is available to staff who need t o know how to handle and dispo se of a me dication s afely. | |||||
540 | User Acces s Levels | |||||
541 | ||||||
542 | User Level | |||||
543 | Role | |||||
544 | Responsibi lities | |||||
545 | Applicatio n Access L evel | |||||
546 | Primary | |||||
547 | Pharmacist Superviso r | |||||
548 | Add, edit, and appro ve product s and new domains | |||||
549 | PPS-N Full Read/Writ e | |||||
550 | Primary | |||||
551 | Environmen tal Engine er (or oth er credent ialed staf f authoriz ed to perf orm the ta sk) | |||||
552 | Add, edit, and appro ve product s and new domains | |||||
553 | PPS-N Full Read/Writ e | |||||
554 | Primary | |||||
555 | Pharmacist / Pharmacy Technicia n | |||||
556 | Look up ha zardous dr ug informa tion | |||||
557 | VistA Look up View/Re ad | |||||
558 | Primary | |||||
559 | Nurse | |||||
560 | Administer medicatio ns | |||||
561 | BCMA View/ Read | |||||
562 | Primary | |||||
563 | Resident P hysicians | |||||
564 | Administer medicatio ns | |||||
565 | BCMA View/ Read | |||||
566 | Primary | |||||
567 | Pharmacist Superviso r | |||||
568 | Verify haz ardous dru g informat ion | |||||
569 | BCMA View/ Read | |||||
570 | ||||||
571 | ||||||
572 | ||||||
573 | ||||||
574 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
575 | Business R equirement s Document 6January 2 015 | |||||
576 | ||||||
577 | Known Inte rfaces and Data Sour ces | |||||
578 | This is th e business community ’s best un derstandin g of known interface s and may not be a c omprehensi ve listing . All lis ted interf aces shoul d be inclu ded in the RTM. | |||||
579 | ||||||
580 | Name of Ap plication | |||||
581 | Descriptio n of curre nt applica tion | |||||
582 | Interface Type | |||||
583 | Existing F unctionali ty | |||||
584 | Expected O utcome | |||||
585 | PPS-N - | |||||
586 | VistA / Lo cal NDF | |||||
587 | PPS-N is a web- base d applicat ion that a llows user s to creat e and revi se pharmac y drug inf ormation. | |||||
588 | PPS-N | |||||
589 | pushes dat a to VistA / Local N DF | |||||
590 | The interf ace exists . The Haza rdous to H andle, Haz ardous to Dispose, P rimary EPA , Waste So rt Code, a nd DOT Shi pping Name fields ar e new. | |||||
591 | VistA rece ives Hazar dous to Ha ndle, Haza rdous to D ispose, Pr imary EPA, Waste Sor t Code, an d DOT Ship ping Name data and p opulates t he appropr iate field s. | |||||
592 | Local NDF – BCMA | |||||
593 | Nursing st aff use BC MA wireles s, point- of-care te chnology w ith an int egrated ba r code sca nner to re cord the a dministrat ion of pat ient medic ations. | |||||
594 | BCMA pulls data from the VistA / Local N DF | |||||
595 | The interf ace exists . Hazardou s to Handl e, Hazardo us to Disp ose, Prima ry EPA, Wa ste Sort C ode, and D OT Shippin g Name fie lds are ne w. | |||||
596 | BCMA recei ves data p opulated i n Hazardou s to Handl e, Hazardo us to Disp ose, Prima ry EPA, Wa ste Sort C ode, and D OT Shippin g Name fie lds. | |||||
597 | Related Pr ojects or Work Effor ts | |||||
598 | There are no active projects o r other wo rk efforts related t o this req uest. | |||||
599 | Service Le vel Requir ements | |||||
600 | Availabili ty | |||||
601 | ||||||
602 | Service Le vel Requir ement (SLR ) Question | |||||
603 | SLR Criter ia | |||||
604 | Descriptio n | |||||
605 | 1. How m uch time s hould the system be available (and how m uch down t ime is acc eptable du e to incid ent [unexp ected] out age)? | |||||
606 | 99.9% (8.7 6 hours do wn time) | |||||
607 | It is envi sioned tha t the syst em(s) be a vailable t o the maxi mum extent possible to support the busin ess. | |||||
608 | 2. When should the system be available (what wil l be the c ore operat ing hours of the sys tem)? | |||||
609 | 24x7 | |||||
610 | 24x7x365 | |||||
611 | 3. How s oon should the syste m fully re cover from an outag e? (Includ es Mean Ti me to Rest ore) | |||||
612 | 2 hours | |||||
613 | Consistent with curr ent servic e level re quirements . | |||||
614 | 4. How m uch data w ill be res tored when outage is recovered ? | |||||
615 | 100% (cont inuous bac k-up) | |||||
616 | Consistent with curr ent servic e level re quirements . | |||||
617 | ||||||
618 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
619 | Business R equirement s Document 7January 2 015 | |||||
620 | ||||||
621 | ||||||
622 | Service Le vel Requir ement (SLR ) Question | |||||
623 | SLR Criter ia | |||||
624 | Descriptio n | |||||
625 | 5. What ti me period should be considered for maint enance per iods? | |||||
626 | After hour s (1800- | |||||
627 | 0600) | |||||
628 | Part of Vi stA mainte nance at t he VAMCs o r part of NDF/PPS-N maintenanc e from the national perspectiv e. | |||||
629 | 6. What standard t ime zone w ill the sy stem opera te in? | |||||
630 | All time z ones | |||||
631 | All time z ones | |||||
632 | Capacity & Performan ce | |||||
633 | ||||||
634 | SLR Questi on | |||||
635 | SLR Criter ia | |||||
636 | Descriptio n | |||||
637 | 1. How m any users will be on the syste m hourly? | |||||
638 | >1000 | |||||
639 | 31,000 uni que BCMA u sers, appr oximately 18,700 nur ses, 8,000 pharmacis ts, and 4, 300 pharma cy technic ians. The enhancemen t will not change th e current capacity. | |||||
640 | 2. How man y transact ions will each avera ge user pe rform each hour? | |||||
641 | >10, max = 47 | |||||
642 | At a natio nal level, there are approxima tely 543,0 00 medicat ions scann ed daily. The averag e number o f scanned medication s per medi cal center is approx imately 3, 300 per da y. The enh ancement w ill not ch ange the c urrent cap acity. | |||||
643 | 3. What are the an ticipated peak user times duri ng the day ? | |||||
644 | Other | |||||
645 | Peak times per day f or process ing these requests a re as foll ows: | |||||
646 | 9 a.m. – 10 a.m. – 25% | |||||
647 | 4 p.m. – 5 p.m. – 2 5% | |||||
648 | 9 p.m. – 10 p.m. – 25% | |||||
649 | Remaining 25% spread between 6 a.m. | |||||
650 | through 11 p.m. | |||||
651 | 4. What is the ant icipated p eak transa ction load (when do you think that there will be t he most tr ansactions being per formed on the system ) during t he day? | |||||
652 | Other | |||||
653 | Peak times per day f or process ing these requests a re as foll ows: | |||||
654 | 9 a.m. – 10 a.m. – 25% | |||||
655 | 4 p.m. – 5 p.m. – 2 5% | |||||
656 | 9 p.m. – 10 p.m. – 25% | |||||
657 | Remaining 25% spread between 6 a.m. | |||||
658 | through 11 p.m. | |||||
659 | 5. How m any new us ers will b e added in one year? | |||||
660 | 0-100 | |||||
661 | Number of users rema ins consis tent with VA hiring and attrit ion rates. | |||||
662 | 6. How m any more ( if any) tr ansactions will be a dded in on e year? | |||||
663 | ||||||
664 | No change in number of inpatie nt medicat ion orders as a resu lt of this enhanceme nt, just m ore detail s for thos e orders. | |||||
665 | 7. What kind of in formation will be st ored (spec ify averag e of each kind per m onth)? | |||||
666 | ||||||
667 | Document s torage is not applic able. It i s transact ion based data. | |||||
668 | ||||||
669 | ||||||
670 | ||||||
671 | ||||||
672 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
673 | Business R equirement s Document 8January 2 015 | |||||
674 | ||||||
675 | ||||||
676 | SLR Questi on | |||||
677 | SLR Criter ia | |||||
678 | Descriptio n | |||||
679 | 8. What kind of se arch capac ity is req uired? | |||||
680 | Medium (11 -1000 per hour) | |||||
681 | Search cap acity (loo k up) woul d remain c onsistent with the c urrent app lications since thes e changes add inform ation to a lready exi sting scre ens in the user inte rface. | |||||
682 | 9. What type of sy stem(s) is /are requi red? | |||||
683 | Local (reg ional) Int ranet (All VA) | |||||
684 | ||||||
685 | 10. Is the re a need for heavy applicatio n reportin g? If yes, when? | |||||
686 | No | |||||
687 | ||||||
688 | Interfaces and Secur ity | |||||
689 | ||||||
690 | SLR Questi on | |||||
691 | SLR Criter ia | |||||
692 | Descriptio n | |||||
693 | 1. Does this syste m interact with othe r existing systems? | |||||
694 | Yes | |||||
695 | The soluti on enhance s the func tionality of PPS-N, the NDF, a nd BCMA. | |||||
696 | 2. Will this syste m require additional monitorin g for Info rmation Te chnology s ystem metr ics? | |||||
697 | No | |||||
698 | The additi on of two new inform ational fi elds will not requir e addition al monitor ing, but s hould be c onsistent under curr ent proced ures relat ed to syst em metrics . | |||||
699 | 3. Will this syste m contain personally identifia ble inform ation, Pro tected Hea lth Inform ation, Hea lth Insura nce Portab ility and Accountabi lity Act ( HIPAA) inf ormation, or other c onfidentia l/regulate d data? | |||||
700 | No | |||||
701 | ||||||
702 | 4. Who w ill be the anticipat ed users o f this sys tem? | |||||
703 | VHA | |||||
704 | Pharmacist s, physici ans, and n urses are expected t o use the enhancemen t. | |||||
705 | Other Cons iderations | |||||
706 | Alternativ es | |||||
707 | The altern ative to i mplementin g the Haza rdous Drug s NDF enha ncement is the statu s quo – i. e., VHA he althcare f acilities continuing to use th e waste ch aracteriza tion repor ts produce d by diffe rent contr actors’ an alyses of hazardous waste phar maceutical s. This is an ineffe ctive mean s of provi ding the i nformation to the us ers who ne ed it, res ults in si gnificant cost to VA , and cont ributes to a lack of standardi zation acr oss sites. | |||||
708 | Assumption s | |||||
709 | The projec t assumes that there will be f unding for the ongoi ng develop ment to de ploy this project as a Class I , enterpri se wide, a pplication . | |||||
710 | ||||||
711 | ||||||
712 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
713 | Business R equirement s Document 9January 2 015 | |||||
714 | ||||||
715 | Dependenci es | |||||
716 | This proje ct is depe ndent upon availabil ity of res ources suc h as fundi ng for the ongoing d evelopment between p rototype a nd Class I , enterpri se wide, r elease/dep loyment. | |||||
717 | The soluti on depends on succes sful imple mentation of the ent erprise sc ope inclus ions outli ned in the Scope and detailed in the Inn ovation #6 65 Hazardo us Pharmac euticals S ystem Desi gn Documen t, which i s located in the Sup porting Do cumentatio n file.4 | |||||
718 | Constraint s | |||||
719 | The soluti on is a pr ototype ru nning in t he Innovat ion sandbo x. Not ru nning in a productio n environm ent could constrain the ongoin g developm ent betwee n prototyp e and Clas s I, enter prise wide , release/ deployment . | |||||
720 | Business R isks and M itigation | |||||
721 | ||||||
722 | ||||||
723 | Business R isks | |||||
724 | Mitigation | |||||
725 | If there i s insuffic ient fundi ng to supp ort conver sion to Cl ass I, the n the cost ly, non- s tandard me ans of ana lyzing haz ardous was te pharmac eutical in formation will conti nue to be employed a nd regulat ory penalt ies may co ntinue to be incurre d. | |||||
726 | Develop ri sk mitigat ion plans to anticip ate fundin g issues a nd identif y continge ncy plans before the issues ar e realized . | |||||
727 | If the inn ovation is n’t deploy ed in at l east one p roduction environmen t, then co nversion t o Class I will be de layed. | |||||
728 | Deploy the innovatio n in at le ast one pr oduction e nvironment as soon a s possible . | |||||
729 | ||||||
730 | ||||||
731 | ||||||
732 | ||||||
733 | ||||||
734 | ||||||
735 | ||||||
736 | ||||||
737 | ||||||
738 | ||||||
739 | ||||||
740 | ||||||
741 | ||||||
742 | ||||||
743 | ||||||
744 | ||||||
745 | ||||||
746 | ||||||
747 | ||||||
748 | ||||||
749 | ||||||
750 | ||||||
751 | ||||||
752 | 4 http://UR L/pasdocs/ supportinf o/20130302 %20Hazardo us%20Drugs %20- | |||||
753 | %20Enhance ment%20to% 20National %20Drug%20 File.zip | |||||
754 | ||||||
755 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
756 | Business R equirement s Document 10January 2015 | |||||
757 | ||||||
758 | Appendix A References | |||||
759 | ||||||
760 | Clean Wate r Act (40 CFR Parts 122 and 40 3) http:/ /www.epa.g ov/agricul ture/lcwa. html | |||||
761 | Hazardous Drugs Enha ncement to the Natio nal Drug F ile New Se rvice Requ est http: //URL/nsrd /Tab_Gener alInfo.asp ?RequestID =20130302 | |||||
762 | Resource C onservatio n and Reco very Act o f 1976 (40 CFR) htt p://www.ep a.gov/agri culture/lr ca.html | |||||
763 | VA Handboo k 6500 – I nformation Security Program h ttp://URL/ vapubs/vie wPublicati on.asp?Pub _ID=638&FT ype=2 | |||||
764 | ||||||
765 | ||||||
766 | ||||||
767 | ||||||
768 | ||||||
769 | ||||||
770 | ||||||
771 | ||||||
772 | ||||||
773 | ||||||
774 | ||||||
775 | ||||||
776 | ||||||
777 | ||||||
778 | ||||||
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792 | ||||||
793 | ||||||
794 | ||||||
795 | ||||||
796 | ||||||
797 | ||||||
798 | ||||||
799 | ||||||
800 | ||||||
801 | ||||||
802 | ||||||
803 | ||||||
804 | ||||||
805 | ||||||
806 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
807 | Business R equirement s Document 11January 2015 | |||||
808 | ||||||
809 | ||||||
810 | Use Printe d Report t o Help Han dle and Di spose of H azardous M edications | |||||
811 | ||||||
812 | ||||||
813 | Print Repo rt | |||||
814 | Hazardous Drug Handl ing and Di sposal – A s Is Pharm acy | |||||
815 | ||||||
816 | Order and Pay for Ha zardous Wa ste Charac terization | |||||
817 | Analyze Ha zardous Me dication W aste at Si te | |||||
818 | Hazardous Waste | |||||
819 | Characteri zation Rep ort | |||||
820 | Usually de livered as a | |||||
821 | spreadshee t mixing g eneric and trade nam es, printe d, and sto red in a l oose leaf binder, ma king it in convenient to refere nce. | |||||
822 | Medical Wa ste | |||||
823 | Management Contracto rs | |||||
824 | VA Pharmac yAppendix BModels | |||||
825 | ||||||
826 | ||||||
827 | ||||||
828 | ||||||
829 | ||||||
830 | ||||||
831 | ||||||
832 | ||||||
833 | ||||||
834 | ||||||
835 | ||||||
836 | ||||||
837 | ||||||
838 | ||||||
839 | ||||||
840 | ||||||
841 | ||||||
842 | ||||||
843 | ||||||
844 | ||||||
845 | ||||||
846 | ||||||
847 | ||||||
848 | ||||||
849 | ||||||
850 | ||||||
851 | ||||||
852 | ||||||
853 | ||||||
854 | ||||||
855 | ||||||
856 | ||||||
857 | ||||||
858 | ||||||
859 | ||||||
860 | ||||||
861 | ||||||
862 | ||||||
863 | ||||||
864 | ||||||
865 | ||||||
866 | ||||||
867 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
868 | Business R equirement s Document 12January 2015 | |||||
869 | ||||||
870 | ||||||
871 | Store Data in Local Site Insta nce | |||||
872 | Hazardous Drug Handl ing and Di sposal – T o Be | |||||
873 | Add New Ha zardous Dr ugs to the National Drug File | |||||
874 | Populate H azardous t o | |||||
875 | Handle | |||||
876 | Database F ield | |||||
877 | Populate H azardous t o Dispo se , Primary EPA Code, Waste Sort Code & DO T Shipping Name | |||||
878 | Database F ields | |||||
879 | ||||||
880 | Push New H azardous D rug | |||||
881 | Data | |||||
882 | Hazardous toHazardou s to | |||||
883 | No | |||||
884 | HandleDisp o se | |||||
885 | Yes | |||||
886 | Yes | |||||
887 | Pharmacy | |||||
888 | Product Sy stem | |||||
889 | - National | |||||
890 | National D rug File | |||||
891 | Pharmacist /Environme ntal Engin eer | |||||
892 | ||||||
893 | ||||||
894 | ||||||
895 | ||||||
896 | ||||||
897 | ||||||
898 | ||||||
899 | ||||||
900 | ||||||
901 | ||||||
902 | ||||||
903 | ||||||
904 | ||||||
905 | ||||||
906 | ||||||
907 | ||||||
908 | ||||||
909 | ||||||
910 | ||||||
911 | ||||||
912 | ||||||
913 | ||||||
914 | ||||||
915 | ||||||
916 | ||||||
917 | ||||||
918 | ||||||
919 | ||||||
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921 | ||||||
922 | ||||||
923 | ||||||
924 | ||||||
925 | ||||||
926 | ||||||
927 | ||||||
928 | ||||||
929 | ||||||
930 | ||||||
931 | ||||||
932 | ||||||
933 | ||||||
934 | ||||||
935 | ||||||
936 | ||||||
937 | ||||||
938 | ||||||
939 | ||||||
940 | ||||||
941 | ||||||
942 | ||||||
943 | ||||||
944 | ||||||
945 | ||||||
946 | ||||||
947 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
948 | Business R equirement s Document 13January 2015 | |||||
949 | ||||||
950 | ||||||
951 | ||||||
952 | Take Preca utions | |||||
953 | ||||||
954 | ||||||
955 | Scan Barco de | |||||
956 | ||||||
957 | Follow Pro per Proced ure for Di spo sing | |||||
958 | Hazardous Drug Handl ing and Di sposal – T o Be Admin ister Haza rdous Medi cation to Patient | |||||
959 | ||||||
960 | Access Bar code Medic ation Admi nistration | |||||
961 | ||||||
962 | Request Me dication I nformation | |||||
963 | Display Ha zardous to Handle Ic on | |||||
964 | ||||||
965 | Display Ha zardous to Dispo se Icon | |||||
966 | ||||||
967 | Return med ication in formation | |||||
968 | Hazardous | |||||
969 | Drug Parti ally Y es | |||||
970 | Used? | |||||
971 | Handling | |||||
972 | HazardYes | |||||
973 | Detected? | |||||
974 | Dispo sal | |||||
975 | HazardYes | |||||
976 | Detected? | |||||
977 | No | |||||
978 | National D rug File | |||||
979 | Nurse/Resi dent Physi cian | |||||
980 | Barcode Me dication A dministrat ion | |||||
981 | ||||||
982 | ||||||
983 | ||||||
984 | ||||||
985 | ||||||
986 | ||||||
987 | ||||||
988 | ||||||
989 | ||||||
990 | ||||||
991 | ||||||
992 | ||||||
993 | ||||||
994 | ||||||
995 | ||||||
996 | ||||||
997 | ||||||
998 | ||||||
999 | ||||||
1000 | ||||||
1001 | ||||||
1002 | ||||||
1003 | ||||||
1004 | ||||||
1005 | ||||||
1006 | ||||||
1007 | ||||||
1008 | ||||||
1009 | ||||||
1010 | ||||||
1011 | ||||||
1012 | ||||||
1013 | ||||||
1014 | ||||||
1015 | ||||||
1016 | ||||||
1017 | ||||||
1018 | ||||||
1019 | ||||||
1020 | ||||||
1021 | ||||||
1022 | ||||||
1023 | ||||||
1024 | ||||||
1025 | ||||||
1026 | ||||||
1027 | ||||||
1028 | ||||||
1029 | ||||||
1030 | ||||||
1031 | ||||||
1032 | ||||||
1033 | ||||||
1034 | ||||||
1035 | ||||||
1036 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1037 | Business R equirement s Document 14January 2015 | |||||
1038 | ||||||
1039 | ||||||
1040 | Determine Hazardous Medication is Partia lly Used, Expired, o r | |||||
1041 | Contaminat ed | |||||
1042 | Follow Cor rect Proce dure to Di spo se of | |||||
1043 | Hazardous Drug | |||||
1044 | Hazardous Drug Handl ing and Di sposal – T o Be Dispo se of Haza rdous Drug s | |||||
1045 | Notify Pha rmacy that Hazardous Drug Need s Dispo sa l | |||||
1046 | ||||||
1047 | Search for Hazardous Drug | |||||
1048 | Details | |||||
1049 | Pass Searc h Criteria to Nation al Drug Fi le | |||||
1050 | ||||||
1051 | ||||||
1052 | Display Re sults | |||||
1053 | ||||||
1054 | ||||||
1055 | Return Res ults | |||||
1056 | National D rug File | |||||
1057 | Pharmacist /Pharmacy Technician / Nurse /Resident | |||||
1058 | VistA Look up | |||||
1059 | Environmen tal Engine er | |||||
1060 | Physician | |||||
1061 | ||||||
1062 | ||||||
1063 | ||||||
1064 | ||||||
1065 | ||||||
1066 | ||||||
1067 | ||||||
1068 | ||||||
1069 | ||||||
1070 | ||||||
1071 | ||||||
1072 | ||||||
1073 | ||||||
1074 | ||||||
1075 | ||||||
1076 | ||||||
1077 | ||||||
1078 | ||||||
1079 | ||||||
1080 | ||||||
1081 | ||||||
1082 | ||||||
1083 | ||||||
1084 | ||||||
1085 | ||||||
1086 | ||||||
1087 | ||||||
1088 | ||||||
1089 | ||||||
1090 | ||||||
1091 | ||||||
1092 | ||||||
1093 | ||||||
1094 | ||||||
1095 | ||||||
1096 | ||||||
1097 | ||||||
1098 | ||||||
1099 | ||||||
1100 | ||||||
1101 | ||||||
1102 | ||||||
1103 | ||||||
1104 | ||||||
1105 | ||||||
1106 | ||||||
1107 | ||||||
1108 | ||||||
1109 | ||||||
1110 | ||||||
1111 | ||||||
1112 | ||||||
1113 | ||||||
1114 | ||||||
1115 | ||||||
1116 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1117 | Business R equirement s Document 15January 2015 | |||||
1118 | ||||||
1119 | ||||||
1120 | Type of St akeholder | |||||
1121 | Descriptio n | |||||
1122 | Responsibi lities | |||||
1123 | Requesters | |||||
1124 | Carolyn Gu towski, | |||||
1125 | Co-Chair, Pharmaceut ical and E nvironment al Program s Subgroup , | |||||
1126 | Pharmaceut ical Manag ement Work group | |||||
1127 | Vaiyapuri Subramania m, Chair, Pharmaceut ical Manag ement Work group | |||||
1128 | Submitted request. S ubmits bus iness requ irements. Monitors p rogress of request. Contribute s to BRD d evelopment . | |||||
1129 | Endorser | |||||
1130 | Rajiv Jain , | |||||
1131 | Assistant Deputy Und er Secreta ry, Health , PCS | |||||
1132 | Endorsed t his reques t. Provide s strategi c directio n to the p rogram. El icits exec utive supp ort and fu nding. Mon itors the progress a nd time li nes. | |||||
1133 | Business O wner/Progr am Office | |||||
1134 | Michael Va lentino, | |||||
1135 | Chief Cons ultant, PC S–PBM | |||||
1136 | Provides f inal appro val of BRD with sign - off auth ority. Pro vides stra tegic dire ction to t he program . Elicits executive support an d funding. Monitors the progre ss and tim e lines. | |||||
1137 | Business S ubject Mat ter Expert s (SME) | |||||
1138 | Margaret R aisch, | |||||
1139 | Staff Phar macist, Ph armacy Ser vice, St. Louis VAMC | |||||
1140 | William Ku las, Envir onmental P rotection Manager, V ISN 1, VA Maine Heal thcare Sys tem | |||||
1141 | Vaiyapuri Subramania m, Associa te Chief C onsultant - PBM | |||||
1142 | Provide ba ckground o n current system and processes . Describe features of current systems, including known prob lems. Iden tify featu res of enh ancement. | |||||
1143 | Technical SMEs | |||||
1144 | Robert Sil verman, Ph armacy Inf ormatics S pecialist, Clinical Informatic s/PBM | |||||
1145 | Don Lees, | |||||
1146 | Pharmacist Specialis t, PBM, Hi nes | |||||
1147 | Provide te chnical ba ckground i nformation about the current s oftware an d requeste d enhancem ents. | |||||
1148 | User SMEs | |||||
1149 | Jonathan B agby, | |||||
1150 | Nurse Cons ultant, Ba r Code Res ource Offi ce (BCRO), Office of Informati cs and Ana lytics (OI A) | |||||
1151 | Stephen Co rma, | |||||
1152 | Pharmacist Consultan t, BCRO, O IA | |||||
1153 | Kim C. Wil liams, | |||||
1154 | Ensure tha t the enha ncements w ill accoun t for curr ent busine ss process es and exi sting soft ware capab ilities. | |||||
1155 | Appendix C Stakeholde rs, Users, and Workg roups Sta keholders | |||||
1156 | ||||||
1157 | ||||||
1158 | ||||||
1159 | ||||||
1160 | ||||||
1161 | ||||||
1162 | ||||||
1163 | ||||||
1164 | ||||||
1165 | ||||||
1166 | ||||||
1167 | ||||||
1168 | ||||||
1169 | ||||||
1170 | ||||||
1171 | ||||||
1172 | ||||||
1173 | ||||||
1174 | ||||||
1175 | ||||||
1176 | ||||||
1177 | ||||||
1178 | ||||||
1179 | ||||||
1180 | ||||||
1181 | ||||||
1182 | ||||||
1183 | ||||||
1184 | ||||||
1185 | ||||||
1186 | ||||||
1187 | ||||||
1188 | ||||||
1189 | ||||||
1190 | ||||||
1191 | ||||||
1192 | ||||||
1193 | ||||||
1194 | ||||||
1195 | ||||||
1196 | ||||||
1197 | ||||||
1198 | ||||||
1199 | ||||||
1200 | ||||||
1201 | ||||||
1202 | ||||||
1203 | ||||||
1204 | ||||||
1205 | ||||||
1206 | ||||||
1207 | ||||||
1208 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1209 | Business R equirement s Document 16January 2015 | |||||
1210 | ||||||
1211 | ||||||
1212 | Type of St akeholder | |||||
1213 | Descriptio n | |||||
1214 | Responsibi lities | |||||
1215 | ||||||
1216 | Director, BCRO, OIA | |||||
1217 | ||||||
1218 | Stakeholde r Support Team (BRD Developmen t) | |||||
1219 | ||||||
1220 | Type of St akeholder | |||||
1221 | Descriptio n | |||||
1222 | Responsibi lities | |||||
1223 | Health Car e Security Requireme nts SME | |||||
1224 | Bill Newha rt, | |||||
1225 | Management and Progr am Analyst , Health C are Securi ty Require ments, Hea lth Inform ation Gove rnance, O IA | |||||
1226 | Responsibl e for dete rmining an d providin g guidance on compli ance with HIPAA. | |||||
1227 | Service Co ordination SME | |||||
1228 | Richard Mu rray, | |||||
1229 | Management Analyst, Service Co ordination , OI&T, Of fice of Cu stomer Adv ocacy | |||||
1230 | Responsibl e for ensu ring all a spects of non-functi onal requi rements ha ve been ac curately r ecorded fo r this req uest. | |||||
1231 | Health Sys tems Portf olio Manag ement Staf f | |||||
1232 | Christy Ga gliano, | |||||
1233 | Program An alyst, Hea lth System s Health I nformatics | |||||
1234 | Serve as t he liaison between t he Program Office (B usiness Ow ner) and P roduct Dev elopment t hroughout the lifecy cle. | |||||
1235 | Strategic Investment Managemen t (SIM), R equirement s Developm ent Manage ment (RDM) | |||||
1236 | Jill Schep pler, Requ irements A nalyst, RD M, VHA | |||||
1237 | Responsibl e for work ing with a ll stakeho lders to e nsure the business r equirement s have bee n accurate ly recorde d for this request. | |||||
1238 | ||||||
1239 | ||||||
1240 | ||||||
1241 | ||||||
1242 | ||||||
1243 | ||||||
1244 | ||||||
1245 | ||||||
1246 | ||||||
1247 | ||||||
1248 | ||||||
1249 | ||||||
1250 | ||||||
1251 | ||||||
1252 | ||||||
1253 | ||||||
1254 | ||||||
1255 | ||||||
1256 | ||||||
1257 | ||||||
1258 | ||||||
1259 | ||||||
1260 | ||||||
1261 | ||||||
1262 | ||||||
1263 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1264 | Business R equirement s Document 17January 2015 | |||||
1265 | ||||||
1266 | Appendix D User Inter face/User Centered D esign Prin ciples | |||||
1267 | User Exper ience enco mpasses di rect and i ndirect in teractions between t he user an d the syst em Improvi ng usabili ty over th e prior ve rsion is a key requi rement for this appl ication. T he Interna tional Org anization for Standa rdization (ISO) defi nes usabil ity as “th e extent t o which a product ca n be used by specifi ed users t o achieve specified goals with effective ness, effi ciency, an d satisfac tion in a specified context of use” (199 8). | |||||
1268 | For an opt imal user experience the syste m must mee t the requ irements o utlined in this sect ion, which involve a ttributes of the app lication a nd the pro cess requi red to ach ieve them. | |||||
1269 | In order t o improve usability of VA-deve loped or p urchased a pplication s, the fol lowing act ions are r equired: | |||||
1270 | In accorda nce with t he Office of the Nat ional Coor dinator fo r Health I nformation Technolog y’s Meanin gful Use S tage 2 fin al ruling, employ an industry recognized User Cent ered Desig n (UCD) pr ocess. The methods f or UCD are well defi ned in doc uments and requireme nts such a s ISO 9241 –11, ISO 1 3407, ISO 16982, Nat ional Inst itute of S tandards a nd Technol ogy Intera gency Repo rt 7741, I SO/Interna tional Ele ctrochemic al Commiss ion 62366, and ISO 9 241-210. Developers will choo se their U CD approac h; one or more speci fic UCD pr ocesses wi ll not be prescribed . | |||||
1271 | Adhere to an industr y recogniz ed User In terface (U I) Best Pr actices Gu ideline or Style Gui de. For e xample, fi rst follow UI guidel ines for t he develop ment platf orm. In i nstances w here platf orm guidel ines are n ot availab le, adhere to VA’s B est Practi ces Guidel ines/Style Guide. | |||||
1272 | Inform req uirements and design s with det ailed huma n factors work produ cts that h ave been/w ill be com pleted for the speci fic projec t. Example s of speci fic human factors ac tivities m ight inclu de heurist ic evaluat ions, site visits, i nterviews, applicati on-specifi c design g uides, and usability testing o n existing systems o r prototyp es. | |||||
1273 | A sound UC D and deve lopment pr ocess base d on human factors s hould incl ude the fo llowing ac tivities: | |||||
1274 | Understand ing of the users, th e users’ t asks, and the users’ environme nts | |||||
1275 | Review of similar or competiti ve systems to inform requireme nts and de sign | |||||
1276 | Heuristic evaluation of prior versions, prototypes , or basel ine applic ations, if applicabl e | |||||
1277 | Iterative design and formative usability testing ( formative usability testing is used to d iscover us ability pr oblems dur ing the de sign and d evelopment process) | |||||
1278 | User risk analysis | |||||
1279 | Summative validation usability testing ( summative usability testing is used to q uantify an d validate usability of a prod uct with m easures of effective ness, effi ciency, us er percept ions, etc. ) | |||||
1280 | To demonst rate high usability, the appli cation sho uld be: | |||||
1281 | Intuitive and easy t o learn, w ith minima l training | |||||
1282 | Effective by allowin g users to successfu lly comple te tasks | |||||
1283 | ||||||
1284 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1285 | Business R equirement s Document 18January 2015 | |||||
1286 | ||||||
1287 | Efficient by allowin g users to complete their work in a mann er consist ent with c linical pr actice and workflow | |||||
1288 | Perceived to have hi gh usabili ty, as dem onstrated by appropr iate surve y measures | |||||
1289 | Designed t o aid user s in meeti ng task go als withou t being an additiona l burden T he system must be re liable and enable us er trust b y providin g: | |||||
1290 | Stable and reliable performanc e | |||||
1291 | Accurate d ata | |||||
1292 | Display of all data that is av ailable in native or interface d systems and intend ed to be a vailable i n the appl ication | |||||
1293 | Accessible informati on related to the so urce of da ta | |||||
1294 | The applic ation shou ld include a modern Graphical User Inter face that allows the user to v iew data f rom multip le sources and inclu de: | |||||
1295 | Integrated display o f structur ed and uns tructured data | |||||
1296 | Rich data visualizat ion and gr aphical di splay of d ata | |||||
1297 | Ability to switch be tween tabu lar and gr aphical da ta views | |||||
1298 | Ability to interact with displ ayed data to obtain additional details r elated to the data a nd source of the dat a | |||||
1299 | User custo mizable co mponents a nd setting s | |||||
1300 | The applic ation must provide f or advance d and up-t o-date sea rching, to include: | |||||
1301 | Fast searc h function ality with auto-comp lete and r eal-time d isplay of matched re sults duri ng typing | |||||
1302 | Search his tory | |||||
1303 | The applic ation must provide f or advance d filterin g capabili ties, to i nclude: | |||||
1304 | Filtering of data ta bles, list s, and gri ds | |||||
1305 | Filtering of search results | |||||
1306 | The applic ation desi gn should be modifie d to: | |||||
1307 | Address th e specific findings from a hum an factors heuristic evaluatio n conducte d on the p rior versi on of the applicatio n | |||||
1308 | Address th e specific findings reported f rom field use of the prior ver sion | |||||
1309 | Address th e specific findings reported f rom usabil ity testin g of the p rior versi on or rele vant proto types | |||||
1310 | ||||||
1311 | ||||||
1312 | ||||||
1313 | ||||||
1314 | ||||||
1315 | ||||||
1316 | ||||||
1317 | ||||||
1318 | ||||||
1319 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1320 | Business R equirement s Document 19January 2015 | |||||
1321 | ||||||
1322 | ||||||
1323 | Appendix E Technical Informatio n | |||||
1324 | Note: This informati on has bee n provided by the si te and has not been validated by Product Developme nt. | |||||
1325 | ||||||
1326 | -- Select Platform - - | |||||
1327 | ||||||
1328 | ||||||
1329 | ||||||
1330 | ||||||
1331 | Enhancemen ts to exis ting VistA Applicati on | |||||
1332 | ||||||
1333 | ||||||
1334 | ||||||
1335 | Technical Product De scription: | |||||
1336 | ||||||
1337 | ||||||
1338 | Product Pl atform | |||||
1339 | Product Ty pe | |||||
1340 | Standards & Conventi ons Commit tee Compli ance for M and Graph ical User Interface | |||||
1341 | Compliance with Sect ion 508 of the Rehab ilitation Act Amendm ents of 19 98 | |||||
1342 | ||||||
1343 | ||||||
1344 | Yes | |||||
1345 | ||||||
1346 | No | |||||
1347 | ||||||
1348 | Unknown | |||||
1349 | Yes | |||||
1350 | ||||||
1351 | No | |||||
1352 | ||||||
1353 | Unknown | |||||
1354 | ||||||
1355 | Language | |||||
1356 | Database | |||||
1357 | Are Databa se Integra tion Agree ments Requ ired? | |||||
1358 | M C++ | |||||
1359 | ||||||
1360 | Java C | |||||
1361 | ||||||
1362 | OtherDelp hi | |||||
1363 | Oracle MS SQL Serve r | |||||
1364 | ||||||
1365 | MS Access | |||||
1366 | ||||||
1367 | Other | |||||
1368 | Yes | |||||
1369 | ||||||
1370 | No | |||||
1371 | ||||||
1372 | Unknown | |||||
1373 | ||||||
1374 | ||||||
1375 | ||||||
1376 | ||||||
1377 | ||||||
1378 | ||||||
1379 | Are automa ted test s cripts ava ilable? | |||||
1380 | If no, are manual te st scripts available ? | |||||
1381 | Yes | |||||
1382 | No | |||||
1383 | Yes | |||||
1384 | No | |||||
1385 | ||||||
1386 | Have test sites been identifie d? | |||||
1387 | If yes, li st the sit es. | |||||
1388 | Yes No | |||||
1389 | ||||||
1390 | ||||||
1391 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1392 | Business R equirement s Document 20January 2015 | |||||
1393 | ||||||
1394 | ||||||
1395 | ||||||
1396 | Has a Regi onal Revie w been per formed? | |||||
1397 | If yes, wh ich Region performed the revie w? | |||||
1398 | Yes | |||||
1399 | No | |||||
1400 | Unknown | |||||
1401 | ||||||
1402 | ||||||
1403 | Does the p roduct use the Socia l Security Number (S SN)? | |||||
1404 | If the pro duct uses the SSN, w hat is the source? | |||||
1405 | If the pro duct uses the SSN, i s the SSN used as se arch crite rion? | |||||
1406 | If the pro duct uses the SSN, i s the SSN stored loc ally in th e product? | |||||
1407 | Yes No | |||||
1408 | ||||||
1409 | Yes No | |||||
1410 | Yes No | |||||
1411 | If SSN is used as a search cri terion, un der what a uthority i s the SSN being used ? Cite aut hority tha t gives pe rmission t o use SSN. | |||||
1412 | ||||||
1413 | ||||||
1414 | Does the a pplication make use of the Int ernational Classific ation of D iseases (I CD) code s et? | |||||
1415 | If yes, (t he applica tion does make use o f the ICD code set), please de scribe? | |||||
1416 | Who is the point of contact fo r question s regardin g ICD-9? | |||||
1417 | Does the a pplication make refe rence to f iles 80 an d 81, the ICD files? | |||||
1418 | Yes | |||||
1419 | No | |||||
1420 | ||||||
1421 | ||||||
1422 | Yes | |||||
1423 | No | |||||
1424 | ||||||
1425 | Does this product su pport mult i-division al facilit ies? NOT A PPLICABLE | |||||
1426 | Does this product us e / introd uce files that need local adap tation? | |||||
1427 | Is there a nything th at may be designed / built tha t will not be portab le? | |||||
1428 | Yes | |||||
1429 | No | |||||
1430 | Don't Kno w | |||||
1431 | Yes | |||||
1432 | No | |||||
1433 | Don't Kno w | |||||
1434 | Yes | |||||
1435 | No | |||||
1436 | Don't Kno w | |||||
1437 | ||||||
1438 | ||||||
1439 | ||||||
1440 | ||||||
1441 | ||||||
1442 | ||||||
1443 | ||||||
1444 | ||||||
1445 | ||||||
1446 | ||||||
1447 | ||||||
1448 | ||||||
1449 | ||||||
1450 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1451 | Business R equirement s Document 21January 2015 | |||||
1452 | ||||||
1453 | Appendix F Acronyms a nd Abbrevi ations | |||||
1454 | ||||||
1455 | Term | |||||
1456 | Definition | |||||
1457 | BCMA | |||||
1458 | Bar Code M edication Administra tion | |||||
1459 | BCRO | |||||
1460 | Bar Code R esource Of fice | |||||
1461 | BRD | |||||
1462 | Business R equirement s Document | |||||
1463 | CFR | |||||
1464 | Code of Fe deral Regu lations | |||||
1465 | DOT | |||||
1466 | Department of Transp ortation | |||||
1467 | EPA | |||||
1468 | Environmen tal Protec tion Agenc y | |||||
1469 | FDA | |||||
1470 | Food and D rug Admini stration | |||||
1471 | HIPAA | |||||
1472 | Health Ins urance Por tability a nd Account ability Ac t | |||||
1473 | ICD | |||||
1474 | Internatio nal Classi fication o f Diseases | |||||
1475 | ISO | |||||
1476 | Internatio nal Organi zation for Standardi zation | |||||
1477 | IT | |||||
1478 | Informatio n Technolo gy | |||||
1479 | NDF | |||||
1480 | National D rug File | |||||
1481 | NSR | |||||
1482 | New Servic e Request | |||||
1483 | OI&T | |||||
1484 | Office of Informatio n and Tech nology | |||||
1485 | OIA | |||||
1486 | Office of Informatic s and Anal ytics | |||||
1487 | OSHA | |||||
1488 | Occupation al Safety and Health Administr ation | |||||
1489 | PBM | |||||
1490 | Pharmacy B enefits Ma nagement | |||||
1491 | PCS | |||||
1492 | Patient Ca re Service s | |||||
1493 | PPS-N | |||||
1494 | Pharmacy P roduct Sys tem - Nati onal | |||||
1495 | RCRA | |||||
1496 | Resource C onservatio n and Reco very Act | |||||
1497 | RDM | |||||
1498 | Requiremen ts Develop ment and M anagement | |||||
1499 | RTM | |||||
1500 | Requiremen ts Traceab ility Matr ix | |||||
1501 | SIM | |||||
1502 | Strategic Investment Managemen t | |||||
1503 | SLR | |||||
1504 | Service Le vel Requir ement | |||||
1505 | SME | |||||
1506 | Subject Ma tter Exper t | |||||
1507 | SSN | |||||
1508 | Social Sec urity Numb er | |||||
1509 | UCD | |||||
1510 | User Cente red Design | |||||
1511 | UI | |||||
1512 | User Inter face | |||||
1513 | VA | |||||
1514 | Department of Vetera ns Affairs | |||||
1515 | VAMC | |||||
1516 | VA Medical Center | |||||
1517 | VHA | |||||
1518 | Veterans H ealth Admi nistration | |||||
1519 | VISN | |||||
1520 | Veterans I ntegrated Service Ne twork | |||||
1521 | ||||||
1522 | ||||||
1523 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1524 | Business R equirement s Document 22January 2015 | |||||
1525 | ||||||
1526 | ||||||
1527 | Term | |||||
1528 | Definition | |||||
1529 | VistA | |||||
1530 | Veterans H ealth Info rmation Sy stems and Technology Architect ure | |||||
1531 | ||||||
1532 | ||||||
1533 | ||||||
1534 | ||||||
1535 | ||||||
1536 | ||||||
1537 | ||||||
1538 | ||||||
1539 | ||||||
1540 | ||||||
1541 | ||||||
1542 | ||||||
1543 | ||||||
1544 | ||||||
1545 | ||||||
1546 | ||||||
1547 | ||||||
1548 | ||||||
1549 | ||||||
1550 | ||||||
1551 | ||||||
1552 | ||||||
1553 | ||||||
1554 | ||||||
1555 | ||||||
1556 | ||||||
1557 | ||||||
1558 | ||||||
1559 | ||||||
1560 | ||||||
1561 | ||||||
1562 | ||||||
1563 | ||||||
1564 | ||||||
1565 | ||||||
1566 | ||||||
1567 | ||||||
1568 | ||||||
1569 | ||||||
1570 | ||||||
1571 | ||||||
1572 | ||||||
1573 | ||||||
1574 | ||||||
1575 | ||||||
1576 | ||||||
1577 | ||||||
1578 | ||||||
1579 | ||||||
1580 | ||||||
1581 | ||||||
1582 | ||||||
1583 | ||||||
1584 | ||||||
1585 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1586 | Business R equirement s Document 23January 2015 | |||||
1587 | ||||||
1588 | Appendix G Approval S ignatures | |||||
1589 | The requir ements def ined in th is documen t are the high level business requiremen ts necessa ry to meet the strat egic goals and opera tional pla ns of the Patient Ca re Service s – Pharma cy Benefit s Manageme nt Office. Further elaboratio n to these requireme nts may be done in m ore detail ed artifac ts. | |||||
1590 | Business O wner | |||||
1591 | Signifies that the c ustomer ap proves the documente d requirem ents, that they adeq uately rep resent the customer’ s desired needs, and that the customer a grees with the defin ed scope. | |||||
1592 | ||||||
1593 | ||||||
1594 | Signed: | |||||
1595 | ||||||
1596 | ||||||
1597 | Michael Va lentino, C hief Consu ltant, PCS – PBMDate | |||||
1598 | ||||||
1599 | ||||||
1600 | Business L iaison | |||||
1601 | Signifies appropriat e identifi cation and engagemen t of neces sary stake holders an d the conf irmation a nd commitm ent to qua lity assur ance and c ommunicati on of busi ness requi rements to meet stak eholder ex pectations . | |||||
1602 | ||||||
1603 | ||||||
1604 | Signed: | |||||
1605 | ||||||
1606 | ||||||
1607 | Shawn Fahe rty, Enter prise Syst ems Manage rDate | |||||
1608 | ||||||
1609 | ||||||
1610 | Requester( s) | |||||
1611 | Signifies that the r equester a pproves th e document ed require ments and that they adequately represent the Class III to Cl ass I tran sition can didate. | |||||
1612 | ||||||
1613 | ||||||
1614 | Signed: | |||||
1615 | ||||||
1616 | ||||||
1617 | Carolyn M. Gutowski, Co-Chair, Pharmaceu tical and Environmen tal Progra ms Subgrou p, VHA Pha rmaceutica l Manageme nt Workgro upDate | |||||
1618 | ||||||
1619 | Signed: | |||||
1620 | ||||||
1621 | ||||||
1622 | Vaiyapuri Subramania m, Chair, VHA Pharma ceutical M anagement WorkgroupD ate | |||||
1623 | ||||||
1624 | ||||||
1625 | ||||||
1626 | ||||||
1627 | ||||||
1628 | ||||||
1629 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1630 | Business R equirement s Document 24January 2015 | |||||
1631 | ||||||
1632 | ||||||
1633 | ||||||
1634 | ||||||
1635 | Functional Subject M atter Expe rt | |||||
1636 | Signifies that the f unctional subject ma tter exper t approves the docum ented requ irements a nd that th ey adequat ely repres ent the Cl ass III to Class I t ransition candidate. | |||||
1637 | ||||||
1638 | ||||||
1639 | Signed: | |||||
1640 | ||||||
1641 | ||||||
1642 | Robert Sil verman, Ph armacy Inf ormatics S pecialist, PBMDate | |||||
1643 | ||||||
1644 | Technical Point of C ontact | |||||
1645 | Signifies that the t echnical p oint-of-co ntact appr oves the d ocumented requiremen ts and tha t they ade quately re present th e Class II I to Class I transit ion candid ate. | |||||
1646 | ||||||
1647 | ||||||
1648 | Signed: | |||||
1649 | ||||||
1650 | ||||||
1651 | Margaret R aischDate | |||||
1652 | ||||||
1653 | ||||||
1654 | ||||||
1655 | ||||||
1656 | ||||||
1657 | ||||||
1658 | ||||||
1659 | ||||||
1660 | ||||||
1661 | ||||||
1662 | ||||||
1663 | ||||||
1664 | ||||||
1665 | ||||||
1666 | ||||||
1667 | ||||||
1668 | ||||||
1669 | ||||||
1670 | ||||||
1671 | ||||||
1672 | ||||||
1673 | ||||||
1674 | ||||||
1675 | ||||||
1676 | ||||||
1677 | ||||||
1678 | ||||||
1679 | ||||||
1680 | ||||||
1681 | ||||||
1682 | ||||||
1683 | Hazardous Drugs – En hancement to Nationa l Drug Fil e | |||||
1684 | Business R equirement s Document 25January 2015 | |||||
1685 | ||||||
1686 | ||||||
1687 | ||||||
1688 | ||||||
1689 | ||||||
1690 | ||||||
1691 | ||||||
1692 | ||||||
1693 | ||||||
1694 | ||||||
1695 | ||||||
1696 | ||||||
1697 | ||||||
1698 | ||||||
1699 | ||||||
1700 | ||||||
1701 | ||||||
1702 | ||||||
1703 | ||||||
1704 | ||||||
1705 | Requiremen ts Traceab ility Matr ix for NSR 20130302 (Hazardous Drugs Enh ancement) | |||||
1706 | ||||||
1707 | ||||||
1708 | Bus Req ID (Unique I dentifier) | |||||
1709 | Business A ctivity (T heme) | |||||
1710 | (BRD-Level 2) | |||||
1711 | Business N eed (Epic) | |||||
1712 | (BRD-Level s 1 and 2) | |||||
1713 | Business R equirement (User Nar rative) | |||||
1714 | (BRD-Level s 1 and 2) | |||||
1715 | Mapping to Business Function F ramework ( Levels 1-3 ) | |||||
1716 | Mapping to Process M odels | |||||
1717 | (Levels 2 and 3) | |||||
1718 | Mapping to Process M odel Eleme nt(s) (Lev els 2 and 3) | |||||
1719 | 470345 | |||||
1720 | Hazardous Drug Manag ement | |||||
1721 | ||||||
1722 | ||||||
1723 | ||||||
1724 | ||||||
1725 | ||||||
1726 | 475255 | |||||
1727 | ||||||
1728 | As a user, I need th e ability to indicat e which ne w drugs ar e identifi ed as haza rdous when they are added to t he formula ry, so tha t the info rmation is available to staff who need t o know how to handle and dispo se of a me dication s afely. | |||||
1729 | ||||||
1730 | 2.2 Promot e Environm ental | |||||
1731 | Health, 2. 3 Promote Clinical P ublic Heal th | |||||
1732 | Add Hazard ous Drugs to the Nat ional Drug File | |||||
1733 | ||||||
1734 | 475259 | |||||
1735 | ||||||
1736 | ||||||
1737 | As a pharm acist, I n eed the ab ility to i ndicate wh ich new dr ugs are id entified a s hazardou s when the y are adde d to the N ational Dr ug File so that Vete rans Healt h Administ ration (VH A) staff w ho handle and dispos e of hazar dous medic ations kno w when to take preca utions to protect th emselves f rom accide ntal expos ure. | |||||
1738 | 2.2 Promot e Environm ental | |||||
1739 | Health, 2. 3 Promote Clinical P ublic Heal th | |||||
1740 | Add Hazard ous Drugs to the Nat ional Drug File | |||||
1741 | Populate H azardous t o Handle D atabase Fi eld, Popul ate Hazard ous to Dis pose, Prim ary EPA Co de, Waste Sort Code & DOT Ship ping Name Database F ields | |||||
1742 | 475266 | |||||
1743 | ||||||
1744 | ||||||
1745 | As an envi ronmental engineer I need the ability to indicate which new drugs are identified as hazard ous when t hey are ad ded to the National Drug File so that Ve terans Hea lth Admini stration ( VHA) staff who handl e and disp ose of haz ardous med ications k now when t o take pre cautions t o protect themselves from acci dental exp osure. | |||||
1746 | 2.2 Promot e Environm ental | |||||
1747 | Health, 2. 3 Promote Clinical P ublic Heal th | |||||
1748 | Add Hazard ous Drugs to the Nat ional Drug File | |||||
1749 | Populate H azardous t o Handle D atabase Fi eld, Popul ate Hazard ous to Dis pose, Prim ary EPA Co de, Waste Sort Code & DOT Ship ping Name Database F ields | |||||
1750 | 470346 | |||||
1751 | ||||||
1752 | As a user, I need to view haza rdous drug identific ation and waste char acterizati on informa tion, so t hat I can safely han dle and di spose of h azardous m edications . | |||||
1753 | ||||||
1754 | 2.2 Promot e Environm ental Heal th, 2.3 Pr omote Clin ical Publi c Health | |||||
1755 | Administer Hazardous Drugs | |||||
1756 | ||||||
1757 | ||||||
1758 | ||||||
1759 | 470347 | |||||
1760 | ||||||
1761 | ||||||
1762 | ||||||
1763 | ||||||
1764 | As a nurse , I need t o view haz ardous dru g identifi cation and waste cha racterizat ion inform ation, so that when I administ er medicat ion to a patien t I know w hen to wea r Personal Protectiv e Equipmen t (PPE) t o protect myself and others fr om exposur e and know how to co rrectly di spose of a ny remaini ng quantit y of the m edication. | |||||
1765 | 2.2 Promot e Environm ental Heal th, 2.3 Pr omote Clin ical Publi c Health | |||||
1766 | Administer Hazardous Drugs | |||||
1767 | Take Preca utions, Sc an Barcode | |||||
1768 | 474620 | |||||
1769 | ||||||
1770 | ||||||
1771 | As a physi cian, I ne ed to view hazardous identific ation and waste char acterizati on informa tion, so t hat when I administe r medicati on to a pa tient I kn ow when to wear Pers onal Prote ctive Equi pment (PPE ) to prote ct myself and others from expo sure and k now how to correctly dispose o f any rema ining quan tity of th e medicati on. | |||||
1772 | 2.2 Promot e Environm ental Heal th, 2.3 Pr omote Clin ical Publi c Health | |||||
1773 | Administer Hazardous Drugs | |||||
1774 | Take Preca utions, Sc an Barcode | |||||
1775 | 475241 | |||||
1776 | ||||||
1777 | ||||||
1778 | As a pharm acist/phar macy techn ician, I n eed to vie w hazardou s drug ide ntificatio n and wast e characte rization i nformation , so that I know whe n I should wear Pe rsonal Pro tective Eq uipment wh en handlin g and corr ectly labe ling hazar dous medic ations for dispensin g and know the corre ct way to dispose of a hazardo us medicat ion when i t is expir ed, contam inated, or partially used. | |||||
1779 | 2.2 Promot e Environm ental Heal th, 2.3 Pr omote Clin ical Publi c Health | |||||
1780 | Dispose of Hazardous Drugs | |||||
1781 | Search for Hazardous Drug Deta ils, Follo w Correct Procedure to Dispose of Hazard ous Drug | |||||
1782 | ||||||
1783 | ||||||
1784 | ||||||
1785 | ||||||
1786 | ||||||
1787 | ||||||
1788 | ||||||
1789 | ||||||
1790 | ||||||
1791 | ||||||
1792 | ||||||
1793 | ||||||
1794 | ||||||
1795 | ||||||
1796 | BUILD 3: P rescriptio n Expirati on Date Mo dification | |||||
1797 | ||||||
1798 | ||||||
1799 | ||||||
1800 | ||||||
1801 | ||||||
1802 | ||||||
1803 | ||||||
1804 | ||||||
1805 | ||||||
1806 | ||||||
1807 | ||||||
1808 | ||||||
1809 | ||||||
1810 | Requiremen ts Traceab ility Matr ix for NSR 20150309 (Fix Rx Ex piration D ate Calcul ation) | |||||
1811 | ||||||
1812 | ||||||
1813 | NSR # | |||||
1814 | Requiremen t Doc | |||||
1815 | Identifier | |||||
1816 | Business N eed | |||||
1817 | (Epic) | |||||
1818 | (BRD-Level s 1 and 2) | |||||
1819 | Business R equirement | |||||
1820 | (User Narr ative) (BR D-Levels 1 and 2) | |||||
1821 | 20150309 | |||||
1822 | ||||||
1823 | 509398 | |||||
1824 | As a pharm acist, I w ant to pro cess | |||||
1825 | only those prescript ion fill r equests th at have be en appropr iately cal culated by the syste m, so that I do not fill presc riptions t hat are co nsidered t o be expir ed based o n DEA regu lations. | |||||
1826 | ||||||
1827 | ||||||
1828 | ||||||
1829 | ||||||
1830 | ||||||
1831 | ||||||
1832 | ||||||
1833 | ||||||
1834 | ||||||
1835 | ||||||
1836 | ||||||
1837 | ||||||
1838 | ||||||
1839 | ||||||
1840 | ||||||
1841 | ||||||
1842 | ||||||
1843 | ||||||
1844 | ||||||
1845 | ||||||
1846 | BUILD 4: P harmacy Pr escription Verificat ion Before Dispensin g | |||||
1847 | ||||||
1848 | NSR 201104 15 Require ments | |||||
1849 | ||||||
1850 | ||||||
1851 | ||||||
1852 | ||||||
1853 | (387403) I nclude Bar code on Bo ttle Label : Redesign prescript ion medica tion bottl e labels t o include the prescr iption med ication ba rcode. Thi s requirem ent incorp orates PSP O 1999. | |||||
1854 | (387407) U se Barcode As Final Gatekeeper : Allow th e prescrip tion medic ation barc ode system functiona lity, alre ady used a nd present ed on the medication s’ associa ted paperw ork, to be used as t he final g atekeeper of all pre scription medication s released to patien ts so that prescript ions can b e intercep ted when n ecessary?? | |||||
1855 | ||||||
1856 | ||||||
1857 | ||||||
1858 | ||||||
1859 | ||||||
1860 | ||||||
1861 | ||||||
1862 | ||||||
1863 | VHA Physic ianOrders Medication | |||||
1864 | #1 for Pat ient with, Believed to be, Inf ection #1 | |||||
1865 | Physician becomes aw are that p atient has Infection #2, not | |||||
1866 | Infection #1 | |||||
1867 | Discontinu es | |||||
1868 | Medication #1 Order | |||||
1869 | Medication #1 is ina ppropriate to treat Infection #2 | |||||
1870 | ||||||
1871 | ||||||
1872 | ||||||
1873 | ||||||
1874 | ||||||
1875 | ||||||
1876 | ||||||
1877 | VAMC Pharm acistThere is no fun ctionality or notifi cation in the prescr iption med ication re lease proc ess that p revents a pharmacist from rele asing a me dication a fter a phy sician dis continues an order a lready pro cessed by a VAMC Pha rmacist. | |||||
1878 | ||||||
1879 | ||||||
1880 | ||||||
1881 | ||||||
1882 | NSR 201104 15 Process | |||||
1883 | Processes Physician Order | |||||
1884 | Prints Pre scription Informatio n | |||||
1885 | ||||||
1886 | Fills Pres cription | |||||
1887 | Releases M edication #1 to Pati ent | |||||
1888 | ||||||
1889 | ||||||
1890 | ||||||
1891 | ||||||
1892 | ||||||
1893 | ||||||
1894 | ||||||
1895 | ||||||
1896 | ||||||
1897 | ||||||
1898 | ||||||
1899 | ||||||
1900 | BUILD 5: S eparate Pa rameters f or Local S uspense Qu eue of Con trolled ve rsus Non-C ontrolled Substance Enhancemen ts | |||||
1901 | ||||||
1902 | NSR 201401 08 Require ments | |||||
1903 | ||||||
1904 | ||||||
1905 | ||||||
1906 | ||||||
1907 | ||||||
1908 | (388533) M edication Parameters : Provide the abilit y for user s to set p arameters for how fa r in advan ce medicat ions shoul d be pulle d for dist ribution i n the Phar macy Data Management package i n VistA. | |||||
1909 | ||||||
1910 | ||||||
1911 | ||||||
1912 | As-Is Proc ess for Se parate Par ameters fo r Local Su spense Que ue of Cont rolled vs. Non-Contr olled Subs tances | |||||
1913 | ||||||
1914 | VHA Facili ty | |||||
1915 | ||||||
1916 | Pharmacy S taff | |||||
1917 | ||||||
1918 | ||||||
1919 | ||||||
1920 | Review Med ication Or ders in Su spense Que ue | |||||
1921 | ||||||
1922 | ||||||
1923 | ||||||
1924 | ||||||
1925 | ||||||
1926 | ||||||
1927 | ||||||
1928 | ||||||
1929 | ||||||
1930 | No | |||||
1931 | ||||||
1932 | Fill based on establ ished para meters? | |||||
1933 | ||||||
1934 | Yes | |||||
1935 | ||||||
1936 | ||||||
1937 | The curren t paramete rs do no a llow users to proper ly balance cost savi ng with pa tient safe ty. | |||||
1938 | ||||||
1939 | ||||||
1940 | ||||||
1941 | Distribute Medicatio n to Patie nt | |||||
1942 | ||||||
1943 | ||||||
1944 | To-Be Proc ess for Se parate Par ameters fo r Local Su spense Que ue of Cont rolled vs. Non-Contr olled Subs tances | |||||
1945 | ||||||
1946 | ||||||
1947 | ||||||
1948 | ||||||
1949 | ||||||
1950 | Pharmacy S taffReview Medicatio n Orders i n Suspense Queue | |||||
1951 | Fill based on establ ished para meters? | |||||
1952 | ||||||
1953 | Yes | |||||
1954 | ||||||
1955 | ||||||
1956 | Distribute Medicatio n to Patie nt | |||||
1957 | ||||||
1958 | ||||||
1959 | NSR 201401 08 Process | |||||
1960 | ||||||
1961 | ||||||
1962 | VHA Facili tyNoThis c hange will allow for more deta iled param eters, | |||||
1963 | which will help user s to prope rly balanc e cost sav ing with p atient saf ety. | |||||
1964 | ||||||
1965 | ||||||
1966 | ||||||
1967 | ||||||
1968 | ||||||
1969 | ||||||
1970 | ||||||
1971 | ||||||
1972 | ||||||
1973 | ||||||
1974 | BUILD 6: I ndividual Patient Sa fety Issue s | |||||
1975 | and Remove Clinic Op tion | |||||
1976 | ||||||
1977 | ||||||
1978 | Patient Sa fety Issue s | |||||
1979 | ||||||
1980 | ||||||
1981 | ||||||
1982 | ||||||
1983 | ||||||
1984 | ||||||
1985 | PSPO #2017 : Outpatie nt Pharmac y prescrip tion label (s) were e dited in V istA Outpa tient Phar macy from Window to Mail, and were fille d and prin ted on Loc al Suspens e two days later. | |||||
1986 | PSPO #2193 : Outpatie nt Pharmac y prescrip tion label (s) did no t print, a nd the pre scription was not di spensed or released. | |||||
1987 | PSPO #2236 : There is a Reprint Default i ssue where by prescri ption refi lls may no t be proce ssed appro priately w hen the la bel reprin t default prompts ar e accepted for CMOP rejects at sites wit h vendor d ispensing devices. | |||||
1988 | PSPO #2462 : Reprint options ar e selectab le on expi red prescr iptions wi thout a wa rning mess age alerti ng to the fact that the prescr iption has expired. | |||||
1989 | ||||||
1990 | ||||||
1991 | Remove Cli nic Option from CPRS Requireme nt | |||||
1992 | ||||||
1993 | ||||||
1994 | ||||||
1995 | ||||||
1996 | ||||||
1997 | ||||||
1998 | RTC Reqt # TBD: Remov e “C (Admi nistered i n Clinic)” | |||||
1999 | from VistA Pharmacy Quick Orde rs in orde r to align with chan ges made i n CPRS by the CPRS 3 2 project. |
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