May-August, 2017/Vol 37/Issue 2 Orgnal Artcle Methodologcal Study to Develop Standard Operatonal Protocol on Intravenous (IV) Drug Admnstraton For Chldren and to Assess ts Implcaton Bjarana SK 1, San SK 2, Verma S 3 Abstract Introducton: Medcne admnstraton forms a major part of the regstered nurse s role. Medcnes are prescrbed by a physcan and dspensed by the pharmacst but responsblty for correct admnstraton rests wth the regstered nurse. Fatal consequences have been noted followng wrong drug, dose, dluent and unsterle technque. The objectve of ths study was to develop standard operatonal protocol (SOP) on Intravenous (IV) drug admnstraton and checklst to assess the mplementatons of the developed SOP. Materal and Methods: A methodologcal research desgn was adapted to carry out the study. Medcne wards (4-B, 4-C, 5-B and 5-C), Emergency room, PICU at Advanced Paedatrc Centre (APC) of Post Graduate Insttute of Medcal Educaton and Research (PGIMER), Chandgarh. Thrty observatons of IV drug admnstraton and 58 bedsde nurses workng durng July- September 2015. A prospectve methodologcal study was performed to generate SOP. Total 17 FGDs were conducted and data was analysed wth SPSS (Verson-20.0). Results: The Content Valdty Index (CVI) of SOP and checklst was 99.77% that means all tems n both SOP and checklst are vald. Cronbach s-alpha was calculated to assess Internal Consstency of checklsts. Over-all standardzed Cronbach s alpha was calculated 0.94 that means all tems n the checklst are nternally consstent and contrbutng to the total relablty of the checklst. All the nurses felt that SOP s useful. Concluson: Vald and feasble SOP for drug admnstraton to chldren through IV route along wth vald and relable checklst was developed. It s recommended to use ths document for drug admnstraton for chldren. Key words: Intravenous, Nurses, Delph-technque, CVI, FGD Introducton S tandard Operatng Protocols (SOPs) are wrtten documents showng the steps of actvtes, necessary to complete tasks accordng to nsttutonal polces 1. In a Health care nsttute SOPs advocate the step-by-step performance of any procedure requred to provde care to the patents by a traned staff 2. It s a helpful wrtten document for newly recruted care provders to perform ther expected servces n that set-up 3. J. Nepal Paedatr. Soc. 1 Sunl Kumar Bjarana, Nursng Offcer, Neonatology, 2 Sushma Kumar San, Lecturer, Natonal Insttute of Nursng Educaton, 3 Sanjay Verma, Assocate Professor, Paedatrc Medcne, Advanced Paedatrc Centre. All from the Post Graduate Insttute of Medcal Educaton and Research, Chandgarh 160012, Inda. Address for correspondence Sunl Kumar Bjarana #239/1, sector 55, Chandgarh 160055, Inda. Tel No; +919478018928 E-mal- sunnn@yahoo.com Acknowledgements: We thank Dr. Sandhya Gha, prncple, NINE to allow us to undertake ths study and Dr. Sunt Sngh, head of paedatrcs to permt us to complete ths study n the medcne wards APC, PGIMER, Chandgarh. The author also apprecates the cooperaton of bedsde nurses and Delph panelsts for the study. We would also extend our grattude to Dr. Sushma Kumar San for provdng language help n wrtng and proof readng the artcle and Mss Sara to make audo recordng of all FGDs. Fundng: Nl Conflct of Interest: Ths study was conducted at Advanced Paedatrc Center (APC), PGIMER, Chandgarh to develop SOP for drug admnstraton for chldren admtted at APC, PGIMER, Chandgarh. Permsson from IRB: Yes How to cte Bjarana SK, San SK, Verma S. Methodologcal Study to Develop Standard Operatonal Protocol on Intravenous (IV) Drug Admnstraton For Chldren and to Assess ts Implcaton. J Nepal Paedatr Soc 2017;37(2):153-158. do: http://dx.do.org/10.3126/jnps.v372.17170 Ths work s lcensed under a Creatve Commons Attrbuton 3.0 Lcense. 153
Standard Operatonal Protocol on IV Drug Intravenous drug admnstraton s the facltaton of safe and effectve admnstraton of medcne and fl ud to neonate/ nfant/ toddler/ preschool/schoolgong. Fatal consequences have been noted followng wrong drug, dose, dluent and unsterle technques 4-6. Nurses are chef partcpant n drug admnstraton and accountable for correct drug admnstraton n ther assgned patents 7,8. Large numbers of drugs are used n Paedatrc Medcne ward accordng to the severty of chld s dsease condton. The avalablty of SOPs for drug admnstraton n such wards can make a dfference n patent s prognoss 9-13. In Medcal Ward, APC, PGIMER, no such document s noted n respect to drug admnstraton. As per author s knowledge none of other nsttute n Inda has a documented well-developed SOPs for drug admnstraton n paedatrc wards. The need for a well-developed drug admnstraton protocol for reducng the errors n drug admnstraton s must n tertary care centres such as PGIMER, Chandgarh. Therefor the present study amed to provde evdencebased lterature for health care provders to help themselves at the tme of drug admnstraton. Materal and Methods Methodologcal research desgn was adapted to develop SOP on IV drug admnstraton for chldren, admtted n Advanced Paedatrc Centre (APC), Post Graduate Insttute of Medcal Educaton and Research (PGIMER), Chandgarh. Insttutonal ethcal commttee PGIMER, Chandgarh approved the study protocol. Permsson to conduct the study was also obtaned from the respectve authorty of the department. Researcher hmself approached all the partcpants and brefl y explaned the purpose of the study. Informed wrtten consent was obtaned from all partcpants before commencement of the study. Partcpant s conf dentalty was mantaned. The data was analyzed by SPSS software (Verson-20.0). Cronbach s-alpha was calculated to assess Internal Consstency of checklsts. The overall Cronbach s-alpha value of checklsts was 0.947. Table- 1 (Part-1 & 2) shows, when corrected tem to total correlaton was appled on 43 tems of tool, 41 tems had tem score to total score correlaton between 0.2-0.953 whereas 2 tems n the tool had tem score to total score correlaton < 0.2 showng ther ncompatblty wth the overall tool. When the ndvdual tem was deleted the value of Cronbach s-alpha was ncreased for 8 tems ncludng one tem whose score to total score correlaton was < 0.2. That means these 8 tems were not contrbutng to the total relablty of tool and could be dscarded. The results were dscussed wth Delph panelsts; all members were n the favor of keepng all tems because they were also equally mportant n SOP even f the low correlaton ndcated n the ndvdual tem score. Results Vald and feasble SOP for IV drug admnstraton for chldren along wth vald and relable checklst was developed. For ready references SOP n the form of booklet and poster s bnder carryng pctures of drug admnstraton technque were made avalable to all medcne unts of APC, PGIMER, Chandgarh. Incluson Crtera Nurses who gave consent to partcpate n ths study were nvolved. Phases of research project 1. Preparaton Phase: Prelmnary draft of SOP and checklst was generated n the followng four steps (a) Assessment of The Current Practces, (b) Lterature was revewed related to standard care practces of IV drug admnstraton, (c) Ten Focus Group Dscussons (FGDs) were conducted and (d) Consultaton wth specalsts of Pedatrc Nursng and Pedatrc Medcne, ncorporatng the results of assessment of current practces and valuable suggestons of bed sde nurses gathered n FGDs. 2. Valdaton Phase: Delph technque was appled for the assessment of content valdty of prelmnary draft. The Delph panel ncluded 13 members from the f eld of Pedatrc Medcne and Nursng. Total four rounds were conducted to develop the SOP. 3. Plot Study (I st Tryout): conducted after thrd round of valdaton that revealed that the exstng pctures n the protocol were not clear. The f nal fourth SOP draft was prepared by replacng exstng pctures n protocol wth clear and afresh pctures. Content Valdty Index (CVI) of SOP and Checklst for all tems was calculated 99.77% after fourth round. 4. Checkng The Relablty (II nd Tryout): was performed at Medcne unts (4-B, 4-C, 5-B and 5-C), Emergency and PICU, APC, PGIMER, Chandgarh. Researcher observed 30 procedures of IV drug admnstraton durng second and thrd week of September 2015. 5. Evaluaton: seven FGDs were conducted to get revews of bedsde nurses about the usefulness of SOP. 154 J. Nepal Paedatr. Soc.
Bjarana SK et. al. Table 1: Relablty of checklst on IV drug admnstraton (Part-1) (N=30) Scale Mean f S.No. Items Item Deleted 1 Selects approprate Supples and Artcles to prepare tray Corrected Item- Total Correlaton Cronbach's Alpha f Item Deleted Compartment tray 4.80 0.589 0.702 Hand santzer 4.80 0.589 0.702 Burette (Paedatrc Drp set (PD set) 4.97 0.464 0.703 v Dluton solutons 4.80 0.589 0.702 v Kdney tray 5.63 0.224 0.745 v Chlorehexdne/ sprt swabs 4.80 0.589 0.702 v Clean or sterle gloves (f requred) 5.17 0.398 0.730 v Paper bag 5.70 0.407 0.714 x Sterle addtonal pack 5.47 0.471 0.706 2 At the tme of drug preparaton Check for any pre-medcaton before medcaton admnstraton Asks the parents about any medcaton allerges and the chld s former responses to drug Opens addtonal pack and open a sterle syrnge nto the opened sterle pad Cleans the cap of val wth sprt swab and let dry the v cap Wthdraws the needle and syrnge and keep them v on sterle pack. Keeps the f lled syrnge n sterle pack and takes t to v the chld wthout showng the needle 3 At the tme of drug admnstraton 6.20 0.187* 0.887 6.57 0.516 0.876 6.87 0.859 0.852 6.27 0.455 0.877 6.87 0.859 0.852 6.87 0.859 0.852 Explans the procedure to the chld /parents clearly usng approprate language and take consent from 6.33 0.473 0.877 parents to admnster drug to the chld Asks the parents about any known medcaton allerges 6.37 0.326 0.886 Keep a dry swab under the cannula hub 6.77 0.721 0.861 v Cleans the whte stopper of cannula 6.20 0.318 0.883 v Keeps the whte stopper on a sterle addtonal pad 6.87 0.859 0.852 v v v x Cleans the cannula hub wth squeezed Chlorehexdne/sprt swab Observes vtals of the chld carefully durng & after admnstraton Uses dvertonal technque whle admnstraton of drug to the chld Stops njecton of the medcne f the chld suddenly becomes lethargc or hyperactve 6.30 0.367 0.882 12.90 0.289 0.950** 12.73 0.543 0.946 13.47-0.112* 0.953** Notes: Overall scale mean s 26.50, Overall relablty s.947 (standardsed Cronbach s alpha), * Items n the tool whch shows tem to total correlaton <0.2, ** Items n the tool whose Cronbach's Alpha value ncreased f Item deleted. J. Nepal Paedatr. Soc. 155
Standard Operatonal Protocol on IV Drug Table 2: Relablty of checklst on IV drug admnstraton (Part-2) (N=30) 1 Items Steps for preparaton of drug wth Burette (PD set) Scale Mean f Item Deleted Corrected Item- Total Correlaton Cronbach's Alpha f Item Deleted Opens the burette from sterle packng and hang over the IV fl ud bottle holder Prmes the burette tubng wth 15 ml of nfuson soluton v Flls the prescrbed amount of nfuson soluton v Cleans the drug nducer port on the burette wth sprt/ Chlorehexdne swab and let dry t v Injects the pref lled medcne n to the burette and mxed thoroughly wth the IV soluton by agtatng the burette several tmes v Dscards 10 ml soluton of prmed tubng 2 Steps for admnstraton of Infuson va Burette (PD set) Clean the njecton port wth an alcohol swab and allow dryng t. 12.83 0.857 0.941 Insert syrnge hub to fl ush the lne wth 2 ml normal salne Check the ste agan for patency v Attach the prmed tubng of burette to the 10 cms extenson or drect to the ven cannula v Adjust drp rate to admnster the soluton at the prescrbed rate by the physcan v Adds 10-15 NS to fl ush the drug n drp set 3 After drug admnstraton to the chld Flushes tubng/cannula wth 5 ml of normal salne or runnng IV flud Prases the chld/ use non-verbal approach for cooperaton Observes the chld for 15-20 mnutes for any sde effects and ask the parents to nform you any untoward sgn/symptoms f appear after drug admnstraton 12.93 0.474 0.947 12.77 0.242 0.950** 13.30 0.408 0.948** v Allow the chld to express hs or her feelng 13.27 0.371 0.950** v Reassures the chld that next tme wll be easer 13.47 0.304 0.948** v v Stay wth chld and gves feed back /nstructon to the chld/parent f requred Remnds/tells the parents about the tmngs of next dose 13.57 0.202 0.948** 13.57 0.202 0.948** Notes: Overall scale mean s 26.50, Overall relablty s.947 (standardsed Cronbach s alpha), * Items n the tool whch shows tem to total correlaton <0.2, ** Items n the tool whose Cronbach's Alpha value ncreased f Item deleted. Dscusson SOPs descrbe the actvtes necessary to complete tasks accordng to nsttutonal regulatons, provncal laws. These are used to remove varaton n procedure performance because every ndvdual develops hs/her own concept of procedure s process on scentf c bass 1. Present study was undertaken because no such SOP on IV drug admnstraton notf ed n APC wards, PGIMER. Intally the revew of lterature was done to check the avalablty of SOPs and checklsts for drug admnstraton worldwde. Only natonal and nternatonal lterature of SOPs and checklsts related to drug admnstraton was not enough to gather suff cent nformaton for development of SOP and checklst. Assessment of current-practces of drug admnstraton was also equally mportant to know about the regular 156 J. Nepal Paedatr. Soc.
Bjarana SK et. al. practces of drug admnstraton. In f ve observatons of IV drug admnstraton at APC, PGIMER, Chandgarh, researchers observed that all bedsde-nurses followed few steps but few were totally gnored though those steps were also equally mportant to be performed. To know the reason of gnorance, a seres of FGDs were conducted. The number of FGDs to be conducted depends upon the purpose of study, along wth the heterogenety of group 14. Another study favors that FGDs should be contnued untl repetton of themes s not started 15. Durng ths study, the saturaton of nformaton was acheved after 10 FGDs. The sze of the group should be of between 6-12 people because large group precludes adequate partcpaton by most members and small group fals to provde sgnfcant greater coverage on the topc 16. In present study all FGDs were conducted wth small group of 6-7 members who had 4-5 years of exclusve-experence of pedatrc bedsde nursng because few gudelnes suggest that smaller groups (4-6 members) are allowed when the members have much experence to share 16,17. On the base of gathered nformaton f nally a prelmnary draft of SOP and checklst was prepared. For further ref nement n the prelmnary draft of protocol and checklst Delph-technque was used. The Delph-technque s well suted as a method for consensus buldng and to establsh content valdty 18. Current study had a heterogeneous Delph panel of 13 experts ncluded seven members of nursng faculty and sx faculty members from pedatrcs medcne. In a Smlar study done by Kaushal et al. Delph members were eleven 19. D'Souza et al. used an nterdscplnary panel of seven natonal and nternatonal experts for development of a tool for assessng preterm nfants 20. George et al. had a panel comprsed of 10 members 21. Delph-technque employs repeated rounds n whch prnted drafts of drug admnstraton procedures are gven to the Delph-panelsts untl a common consensus s reached. In the present study, though the consensus of panelsts was acheved after thrd round but few changes were requred after f rst tryout. To make these changes feasble fourth round was conducted before development of f nal verson of SOP and checklst. In smlar studes conducted by Kaushal et al. common consensus was reached n four Delphrounds 19, accordng to George et. al. three rounds were suff cent 21. The overall CVI of current study from the panel of experts was calculated 99.77% ndcatng the valdty of the ndvdual tem. In a smlar study, conducted by D'Souza et al. the overall CVI was 95% 20. The relablty of these Checklsts was ensured by Cronbach s alpha to determne the nternal consstency or average correlaton of tems n a survey-nstrument to gauge ts relablty 22. The overall Cronbach s alpha value of checklsts was 0.947 and tem score correlaton to overall score was n-betweens 0.2-0.953. In a smlar study by George et al. overall value of alpha was 0.76 21. Another study Kaushal et al. revealed Cronbach s alpha value 0.97 19. The corrected tem to total correlaton was appled upon 43 tems of tool, 41 tems had tem score to total score correlaton between 0.2-0.953 whereas two tems n the tool had tem score to total score correlaton < 0.2 showng ther ncompatblty wth the overall tool. When the ndvdual tem was deleted the value of Cronbach s alpha was ncreased for 8 tems ncludng one tem whose score to total score correlaton was < 0.2. That means these 8 tems were not contrbutng to the total relablty of tool and could be dscarded. The results were dscussed wth Delph-panelsts; all members were n the favor of keepng all tems because they were also equally mportant n SOP even f the low correlaton ndcated n the ndvdual tem score. Concluson No nsttutes n Inda have documented any welldeveloped SOPs for IV drug admnstraton n paedatrc wards. SOP on IV drug admnstraton s establshed whch s vald and feasble along wth relable and vald checklsts. It s recommended to use ths SOP for IV drug admnstraton for chldren at all levels (prmary, secondary and tertary). Checklst should be used by nurse admnstrators to assess the mplementaton of SOP. References 1. Stup R. Standard operatng procedures: a wrtng gude. Dary Allance, Penn state unversty, 2001. http://www.daryallance.com/hrmgmt/ organzatonal dev/sopmanual.pdf (accessed on 10 Nov 2014) 2. Bed S, Behera SD, Arya SK, Sngh S. Standard Operatng Procedures n hosptals- A realty check. J Acad Hosp Adm 2006;18(1):1-7. 3. Banca A, Demand M. The Importance of Standard Operatng Procedures n Organzatons. Houston chroncle, 2014. http://smallbusness.chron.com/ mportance-standard-operatng-proceduresorganzatons-69530.html (accessed on 10 Nov 2014) 4. Cousns D. Medcaton errors n ntravenous drug preparaton and admnstraton: a multcentre audt n the UK, Germany and France. Qual Saf Health Care 2005;14(3):190-5. J. Nepal Paedatr. Soc. 157
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