PSNC Briefing n the NHS Cmplaints prcedure (frm 1 April 2009) Under the prvisins f the Natinal Health Service (Pharmaceutical Services) Regulatins 2005 1 pharmacy cntractrs are required t make arrangements fr the handling and cnsideratin f cmplaints. These arrangements must ensure: cmplaints are dealt with efficiently; cmplaints are prperly investigated; cmplainants are treated with respect and curtesy; cmplainants receive, s far as is reasnably practical assistance t enable them t understand the prcedure in relatin t cmplaints; r advice n where they may btain such assistance; cmplainants receive a timely and apprpriate respnse; cmplainants are tld the utcme f the investigatin f their cmplaint; and actin is taken if necessary in the light f the utcme f a cmplaint. Majr changes The new regulatins intrduce several majr changes which are described in detail belw. These are: Each pharmacy must appint a respnsible persn ; Oral cmplaints dealt with t the satisfactin f the cmplainant n later than the fllwing day d nt need t be handled under the new prcedures; The time limit fr making cmplaints increases frm 6 t 12 mnths; The pharmacy must ffer t discuss handling f the cmplaint and setting the time fr a respnse, with the cmplainant; The maximum time fr respnding t a cmplaint increases t six mnths; An annual reprt abut cmplaints must be published, made available t anyne wh requests it, and be sent t the PCT. Respnsible Persn The first majr change intrduced in April 2009 is that the pharmacy cntractr is required t designate a respnsible persn, t be respnsible fr ensuring cmpliance with the arrangements and in particular ensuring that actin is taken if necessary in the light f the utcme f a cmplaint. 1 The regulatins have been amended by The Lcal Authrity Scial Services and Natinal Health Service Cmplaints (England) Regulatins 2009 which applies frm 1 April 2009 PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 1 f 8
The respnsible persn is required t be the chief executive fficer f the cmpany, r if the pharmacy cntractr is a partnership, must be ne f the partners. In the case f a pharmacy business perated by a sle prprietr, the respnsible persn must be that sle prprietr. The functins f the respnsible persn may be perfrmed by any persn authrised by the pharmacy cntractr t act n behalf f the respnsible persn but ultimately, the respnsibility fr ensuring cmpliance remains with the chief executive, partner r sle prprietr as apprpriate. Cmplaints Manager The pharmacy cntractr is required t designate a cmplaints manager, t be respnsible fr managing the prcedures fr handling and cnsidering cmplaints in accrdance with the arrangements. The cmplaints manager need nt be an emplyee, culd be the same persn as the respnsible persn, r culd even be a cmplaints manager designated by anther pharmacy cntractr. The functins f the cmplaints manager may be perfrmed by any persn authrised by the respnsible bdy t act n behalf f the cmplaints manager. Wh can make a cmplaint A cmplaint can be made by the persn wh receives services frm, r wh is r is likely t be affected by an act, missin r decisin f the pharmacy cntractr. A cmplaint can als be made by a representative f persn wh: has died; is a child (a persn under the age f 18 years); is unable t make a cmplaint because f a physical incapacity r lack f mental capacity 2 ; has requested the representative t act n their behalf. Where the cmplaint is made n behalf f a child, the pharmacy cntractr must nt cnsider the cmplaint unless satisfied that there are reasnable grunds fr the cmplaint being made by the representative instead f the child. The pharmacy cntractr must als nt cnsider r further cnsider the cmplaint unless satisfied that the representative is cnducting the cmplaint in the best interests f the child. If the pharmacy cntractr des nt believe there are reasnable grunds fr the representative making the cmplaint, r is nt cnducting the cmplaint in the best interests f the child, the representative must be ntified in writing, with the reasns why the pharmacy cntractr is nt cnsidering the cmplaint made via the representative. Where the cmplaint is made n behalf f a persn wh is unable t make the cmplaint because f a lack f mental capacity, the pharmacy cntractr must nt cnsider r further cnsider the cmplaint unless satisfied that the representative is cnducting the cmplaint in the best interests f the persn n whse behalf the cmplaint is made. If the pharmacy cntractr des nt believe the representative is cnducting the cmplaint 2 Within the meaning f the Mental Capacity Act 2005 PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 2 f 8
in the best interests f the persn n whse behalf the cmplaint is made, the representative must be ntified in writing, with the reasns why the pharmacy cntractr is nt cnsidering the cmplaint made via the representative. Duty t handle cmplaints A pharmacy cntractr has a duty t handle cmplaints under the regulatins nly abut the pharmaceutical services prvided under arrangements with an NHS bdy, such as a PCT. Where a cmplaint is made t a pharmacy cntractr but it appears t the pharmacy cntractr that it shuld have been made t anther bdy, the pharmacy cntractr shuld, with the cnsent f the cmplainant, send the cmplaint nt that bdy. If a cmplaint is made t a PCT abut the services prvided under arrangements with the PCT by a pharmacy cntractr, the PCT must ask the cmplainant whether the cmplainant cnsents t details f the cmplaint being sent t the pharmacy cntractr. If the cmplainant cnsents, the PCT must as sn as reasnably practicable send details f the cmplaint t the pharmacy cntractr. If the PCT cnsiders that it is apprpriate fr it t deal with the cmplaint, it must ntify the cmplainant and the pharmacy cntractr and must cntinue t handle the cmplaint in accrdance with the regulatins. But, if the PCT cnsiders that it is mre apprpriate fr the cmplaint t be dealt with by the pharmacy cntractr, and the cmplainant cnsents, the PCT must ntify the cmplainant and the pharmacy cntractr Where cmplaints have been frwarded by the PCT r anther bdy t a pharmacy cntractr, the cmplaint is deemed t have been made by the cmplainant. Cmplaints that are nt required t be dealt with The fllwing cmplaints are nt required t be dealt with under the NHS arrangements: a cmplaint which is made rally and is reslved t the cmplainant s satisfactin nt later than the next wrking day after the day n which the cmplaint was made; a cmplaint the subject matter f which is the same as that f an ral cmplaint that has previusly been made and reslved t the cmplainant s satisfactin as abve; a cmplaint by a respnsible bdy (e.g. anther pharmacy cntractr r a PCT) but where the cmplaint has simply been frwarded by ne f these bdies as abve, the pharmacy cntractr is under a duty t deal with the cmplaint; a cmplaint the subject matter f which has previusly been investigated under the current Regulatins r a cmplaint made befre 1 April 2009 which has been investigated under a relevant cmplaints prcedure; a cmplaint the subject matter f which is being r has been investigated by a Health Service Cmmissiner under the Health Service Cmmissiners Act 1993; PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 3 f 8
a cmplaint arising ut f the alleged failure by the pharmacy cntractr t cmply with a request fr infrmatin under the Freedm f Infrmatin Act 2000. The secnd significant change is shwn in the first f the abve bullet pints where recgnitin is given that sme cmplaints can be handled with minimal frmality. Where a cmplaint has been made rally and has been reslved t the cmplainant s satisfactin nt later than the next wrking day, then the cmplaint des nt have t be dealt with under the detailed Regulatins. If the pharmacy cntractr decides that a cmplaint is nt required t be dealt with, fr ne f these reasns, it must as sn as reasnably practicable ntify the cmplainant in writing f its decisin and the reasn fr the decisin (this des nt apply t the cmplaints made rally and which have been reslved t the cmplainant s satisfactin). Duty t c-perate with ther bdies Where a pharmacy cntractr passes a cmplaint t anther bdy such as anther pharmacy cntractr r the PCT, r is passed a cmplaint by anther bdy, bth the pharmacy cntractr and that ther bdy have a duty t c-perate t ensure that the handling f the cmplaint is crdinated and ensuring the cmplainant receives a crdinated respnse. Each bdy must, in particular seek t agree which f the bdies shuld take the lead in crdinating the handling f the cmplaint and cmmunicating with the cmplainant; prvide t the ther bdy infrmatin relevant t the cmplaint that is reasnably requested by the ther bdy; and t attend r ensure it is represented at any meeting reasnably required in cnnectin with cnsideratin f the cmplaint. Time limit fr making a cmplaint The third majr change is that a cmplaint must be made n later than 12 mnths after the date n which the matter which is the subject f the cmplaint ccurred; r if later, the date n which the matter came t the ntice f the cmplainant. Prir t 1 April 2009 the time limit was 6 mnths. If, the pharmacy cntractr is satisfied that the cmplainant had gd reasn fr nt making the cmplaint within this time limit, and that it is still pssible t investigate the cmplaint effectively and fairly, then the time limit des nt apply. Frm f Cmmunicatins If the cmplainant cnsents (and has nt withdrawn that cnsent) any cmmunicatin with the cmplainant required by the regulatins can be sent electrnically. When sending electrnically, the requirement fr a signature is met if the persn authrised t send the cmmunicatin types their name r prduces their name using a cmputer r ther electrnic means. Prcedure befre investigatin A cmplaint may be made rally, in writing r electrnically, but if made rally the pharmacy cntractr must make a written recrd f the cmplaint and prvide a cpy f this recrd t the cmplainant. The pharmacy cntractr must acknwledge the cmplaint nt later than 3 wrking days after the date n which the cmplaint is received. Wrking days under these PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 4 f 8
regulatins means Mndays t Fridays which are nt Christmas Day, Gd Friday r a Bank Hliday. The acknwledgement may be made rally r in writing. PSNC has prepared a number f tls which may be used by pharmacy cntractrs, and these can be dwnladed blw. The use f these templates are nt mandatry. The first template, is a letter t acknwledge the receipt f a cmplaint. Acknwledgment letter The furth majr change under these regulatins is that at the time f acknwledging the cmplaint, the pharmacy cntractr must ffer t discuss with the cmplainant, at a time t be agreed with the cmplainant - the manner in which the cmplaint is t be handled; and the respnse perid within which the investigatin f the cmplaint is likely t be cmpleted; and the final respnse is likely t be sent t the cmplainant. The time fr respnse is nw 3 fr the pharmacy cntractr and cmplainant t agree (but this shuld nt nrmally exceed six mnths see later). If the cmplainant des nt accept the ffer f a discussin the pharmacy cntractr must determine the respnse perid and ntify the cmplainant in writing f that perid. Investigatin and respnse A pharmacy cntractr must investigate the cmplaint in a manner apprpriate t reslve it speedily and efficiently and during the investigatin, keep the cmplainant infrmed, as far as reasnably practicable, as t the prgress f the investigatin. During an investigatin, it may be necessary t interview the cmplainant, members f staff, r thers wh are able t give an accunt which may help establish the facts. PSNC has prepared a template interview recrd which may be useful. Cmplaint Interview Frm As sn as reasnably practicable after cmpleting the investigatin, the pharmacy cntractr must send the cmplainant in writing a respnse, signed by the respnsible persn, which includes a reprt which includes the fllwing matters an explanatin f hw the cmplaint has been cnsidered; and the cnclusins reached in relatin t the cmplaint including any matters fr which the cmplainant r pharmacy cntractr cnsiders remedial actin is needed; and cnfirmatin as t whether the pharmacy cntractr is satisfied that any actin needed in cnsequence f the cmplaint has been taken r is prpsed t be taken; 3 Prir t 1 April 2009 the time fr respnse was 25 days PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 5 f 8
details f the cmplainant s right t take their cmplaint t the Health Service Cmmissiner under the 1993 Act (prir t 1 April 2009 the ptin fr a cmplainant wh is nt satisfied with the utcme was t ask the Healthcare Cmmissin t cnsider the cmplaint). The fifth significant change intrduced by the new regulatins is that the pharmacy cntractr has up t six mnths in which t make the respnse t the cmplainant. Althugh the time limit is increased, the principles f Making Experiences Cunt include ensuring the cmplainant receives a timely respnse. The regulatins recgnise that sme investigatins may take lnger than the frmer limit f 25 days, but this shuld nt be seen as a reasn t delay the investigatin r respnse. If the pharmacy cntractr des nt send the cmplainant a respnse within 6 mnths f receipt r such lnger perid as agreed befre the end f that 6 mnth perid between the pharmacy cntractr and the cmplainant, the pharmacy cntractr must ntify the cmplainant in writing and explain the reasn why; and send the cmplainant in writing a respnse as sn as reasnably practicable. Because f the pssibility that the cmplainant made the cmplaint in rder t gain infrmatin s as t pursue a civil claim against the pharmacy cntractr r staff, it may be helpful t ask the prfessinal indemnity insurer fr advice n the prpsed respnse, befre it is dispatched. Publicity Each pharmacy cntractr must make infrmatin available t the public as t its arrangements fr dealing with cmplaints; and hw further infrmatin abut thse arrangements may be btained. PSNC has prepared three templates which pharmacy cntractrs may find helpful. The first is a flyer that publicises the fact that the pharmacy has a cmplaints prcedure. Cmplaints Flyer The secnd template is the prcedure that the pharmacy uses fr dealing with Suggestins, Cmments and Cmplaints. Suggestins, Cmments and Cmplaints Prcedures The third is a frm which a user f the pharmacy services can cmplete t make suggestins, cmments r cmplaints. Suggestins, Cmments and Cmplaints frm Under the clinical gvernance framewrk, a pharmacy is required t publish a practice leaflet. One f the items within that leaflet is hw t find ut mre abut services ffered, cmment n thse services, r make a cmplaint ; The pharmacy practice leaflet culd simply refer t the availablility f a Suggestins, Cmments and Cmplaints leaflet. Mnitring Fr the purpse f mnitring the arrangements each pharmacy cntractr must maintain a recrd f the fllwing matters each cmplaint received; the subject matter and utcme f each cmplaint; and PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 6 f 8
where the pharmacy cntractr infrmed the cmplainant f the respnse perid; r any amendment t that perid, whether a reprt f the utcme f the investigatin was sent t the cmplainant within that perid r any amended perid. PSNC has prepared a template cmplaint recrd, which cntains all the necessary detail, and which can be used t ensure each step f the cmplaints prcess is fllwed. Cmplaint Recrd Frm Annual reprts The final majr change intrduced frm 1 April 2009 is that each pharmacy cntractr must prepare an annual reprt fr each year, ending 31 March, which must specify the number f cmplaints which the pharmacy cntractr received; specify the number f cmplaints which the pharmacy cntractr decided were well-funded; specify the number f cmplaints which the pharmacy cntractr has been infrmed have been referred t the Health Service Cmmissiner t cnsider under the 1993 Act; and summarise the subject matter f cmplaints that the pharmacy cntractr received; any matters f general imprtance arising ut f thse cmplaints, r the way in which the cmplaints were handled; any matters where actin has been r is t be taken t imprve services as a cnsequence f thse cmplaints. The annual reprt must be available t any persn n request. The pharmacy cntractr must als send a cpy f its annual reprt t the PCT which arranged fr the prvisin f the services by the pharmacy cntractr as sn as reasnably practicable after the end f the year t which the reprt relates. T assist pharmacies, PSNC has prepared a template summary f cmplaints, which can be used as an index f cmplaints as they are received and clsed. All the infrmatin necessary t prduce the annual reprt can then be cllated frm this summary at the end f each year. Summary f Cmplaints PCTs may ask pharmacies t prduce evidence during mnitring visits, that they are cmplying with the cmplaints regulatins. Prducing the summary f cmplaints, with cllated cpies f the cmplaints regulatins will prvide evidence, but the detail n these frms cntains sensitive persnal infrmatin abut the cmplainant s shuld nt be disclsed unless the cmplainant has cnsented. If the PCT has decided t investigate a cmplaint made t it, then disclsure f the infrmatin in the pharmacy s cmplaint recrd may be apprpriate. PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 7 f 8
Transitinal arrangements Any cmplaint received by a pharmacy cntractr befre 1 April 2009 shuld, if nt cncluded, cntinue t be handled in accrdance with the cmplaints prcedures that were in place befre 1 April 2009. Hwever, any cmplaint that was t be cnsidered by the Healthcare Cmmissin (i.e. ne that was nt satisfactrily reslved by the pharmacy cntractr) will, after 1 April 2009 be cnsidered t be a request t the Health Service Cmmissiner t cnsider the cmplaint under the 1993 Act. Further guidance During the pilting f the new cmplaints prcedures, the need t be able t supprt peple wh wish t make cmplaints was identified. The fllwing are nt part f the Regulatins, but prvide sme backgrund which may be helpful. Supprt fr peple wh wish t make a cmplaint Independent advcacy is an imprtant means f prviding supprt t cmplainants. In Making Experiences Cunt the Department f Health indicated that advcacy shuld be a right fr anyne wh needs supprt in raising a cmplaint abut health r scial care services. Thrugh the Early Adpter prgramme the Department f Health will be lking at hw independent advcacy can best be prvided, cmparing the different mdels that are currently in place. The findings frm the Early Adpter sites will help the Department t decide hw advcacy will be prvided in line with the new cmplaints arrangements in 2009. The changes intrduced frm 2009 fllw extensive cnsultatin and pilting f the revised prcedures. The Department f Health has published a number f resurces n http://www.dh.gv.uk/mec. The main guidance that can be fund n that site is entitled Listening, respnding, imprving: A guide t better custmer care. There are als dcuments prviding guidance n investigating cmplaints, jint wrking n cmplaints and dealing with serius cmplaints. Prfessinal Guidance The Ryal Pharmaceutical Sciety fact sheet 8 deals with dispensing errrs. This als prvides a useful resurce fr pharmacists wh are faced with a cmplaint, if an errr is the cause. http://www.rpsgb.rg/pdfs/factsheet8.pdf Pharmacy cntractrs shuld remember that if a cmplaint is made as the result f an errr r ther patient safety incident, they shuld make a recrd f the incident and shuld reprt the incident t the Natinal Patient Safety Agency, if an internet cnnectin is available in the pharmacy. The PSNC website has templates fr recrding patient safety incidents and further guidance n reprting incidents t the Natinal Patient Safety Agency - http://www.psnc.rg.uk/pages/essential_service_clinical_gvernance.html PSNC Briefing n the Cmplaints Prcedures (further cpies f this frm can be dwnladed frm www.psnc.rg.uk) Page 8 f 8