Implementation of the FIRM (Foley Insertion, Removal, and Maintenance) protocol in skilled nursing facilities Murthy Gokula a and Phyllis M. Gaspar a 1 aUniversity of Toledo Health Science Campus, Toledo, OH 43614 The purpose of this study was to determine the feasibility and outcomes of the implementation of an evidence based protocol, Foley Insertion Removal and Maintenance (FIRM) for the use and care management of indwelling urinary catheters (IUC) for skilled nursing facilities (SNF). The protocol consists of an order set for insertion, maintenance, and removal complemented with an ed- ucation program for health care providers of SNF. It was imple- mented over a six month period in two SNF. Prospective chart review following implementation revealed an 11.3 rate of IUC per month. Documentation of the indication for placement of an IUC was 98.5%. Retrospective chart review revealed a lower use of IUC prior to implementation of the protocol but the lack of doc- umentation of orders for IUC artificially reduced the rate. FIRM protocol is advocated as a facility policy with a nurse champion to facilitate implementation and surveillance. urinary catheters | skilled nursing facilities The percent of skilled nursing facility (SNF) residents who haveindwelling urinary catheter (IUC) over the last decade varies be- tween 4.5-14 % of the resident population (1,2). This rate has re- mained static with similar rates reported in the 1990s (3,4). A retro- spective study using the minimum data set (MDS) of 2003 found the prevalence of IUC to be 12.6% at admission and 4.5% at annual as- sessment (p<.001). Even though the prevalence may not be perceived as a major problem, the complications of IUC raise inappropriate use as a quality care concern. The concern was addressed by the Centers for Medicare and Medicaid Services (CMS) with the lack of a valid medical justifi- cation for the use of IUC identified as a publicly reported quality measure (5,6,7). Quality standards indicate that residents entering a facility without a urinary catheter should not be catheterized unless an appropriate medical indication is present. Only four absolute indica- tions for urinary catheterization beyond 14 days have been identified by CMS (7). These four indications are: 1. Urinary retention that could not be otherwise corrected and was characterized by post-void residual volumes greater than 200 mL; 2. Infeasibility of intermittent catheterization and persistent over- flow, symptomatic infection or renal dysfunction; 3. Poorly healing Stage 3 or 4 pressure ulcers in which urine con- tamination impedes healing; and 4. Terminal illness or severe impairment when repositioning would be uncomfortable or painful. Long term use of IUC is associated with increased risk of UTI and bacteremia with mortality three times higher than among non- catheterized residents (4,8,9). In studies of residents of SNF, the use of IUC has been found to increase the number of hospitalizations, duration of hospitalization, and use of antimicrobial drugs by three fold (8). Moreover, IUC are an added concern as they are one point restraints (10). A recent study by Mody et al. (11) raises a concern about the adequacy of the knowledge of health care workers of SNF related to the evidence based recommendations in the use and care of IUC. The survey responses of 356 health care workers of seven SNF indicated that there were deficits in knowledge about several research based recommendations including: not disconnecting the catheter from its bag, not routinely irrigating the catheter, and hand hygiene after ca- sual contact. Yet it was encouraging that over 90% of staff were aware of measures such as cleaning around the catheter daily, glove use, and hand hygiene with catheter manipulation. Reports of a reduction in IUC as a result of implementation of comprehensive programs in acute care are numerous. However, re- ports about programs implemented in SNF are limited. Von Preyss- Friedman (12) implemented a QI project in a SNF focused on IUC and included guidelines for IUC use, follow up audit process, and an in-service of nursing staff. A reduction from 67 to 25 residents with an IUC was reported following the implementation. The reduction of IUC resulted in a decrease in the number of catheter associated uri- nary tract infections (CAUTIs). The FRIM protocol, which was suc- cessfully implemented in an acute care facility by the authors (13), and incorporated the approaches used by Von Preyss-Friedman, pro- vided a strong foundation for changing practice based on evidence based systematic approaches for the SNF setting. This study was conducted to determine the feasibility and out- comes of the implementation of the evidence based FIRM (Foley Insertion Removal and Maintenance) protocol revised for the SNF regarding the use and maintenance care of IUC in the long term care setting. The outcomes explored were the rate of IUC use, and doc- umentation of indication for use and of care maintenance strategies. In addition the occurrence of CAUTI occurrence and associated an- tibiotic orders were explored. FIRM Protocol The FIRM Protocol was adapted for a SNF population from a FIRMS protocol developed and implemented by the authors in an acute care setting (13). The protocol includes the FIRMS (Foley Insertion, Removal, and Maintenance Sheet) order sheet, comple- mented with an education program for health care providers. The FIRMS is a one page document that provides the orders for use, removal and maintenance care (Appendix A). Following an order for the insertion of an IUC, the nurse reviews the FIRMS with the provider regarding indication, justification, alternative option and re- moval order. The back page of the FIRMS reviews key evidence based aspects of the care management of IUC. These key aspects are implemented in conjunction with the policy and procedures of the institution. (Appendix A). The education program was offered for health care providers and licensed nursing staff members at each facility. The one hour pro- 1To whom correspondence should be sent: Phyllis.Gaspar@utoledo.edu Author contributions: MG developed the FIRMS protocol,PG & MG designed the research protocol; all authors contributed to the manuscript and MG & PG take responsibility for the paper as a whole. The authors declare no conflict of interest Freely available online through the UTJMS open access option 10–12 UTJMS 2014 Vol. 1 utdr.utoledo.edu/Translation gram included content on the indications for use, correct insertion and removal techniques, care management strategies and complications. The process for implementation of the FIRMS was discussed. The FIRM Protocol (available as a supplementary file, Appendix A) was implemented following completion of the education session at each facility. The Director of Nursing was actively involved in implementation of FIRMS in each facility. The monthly use of the FIRMS order sheet was provided to the Director of Nursing for feed- back purposes and to serve as part of the facilities quality improve- ment initiative. Methods This study used a prospective chart review to determine out- comes of the implementation of the FIRMS protocol. These out- comes are compared with the pre-intervention rates. Approval to conduct the study was obtained from the IRB of The University of Toledo. A retrospective review of charts of residents identified as having an IUC was necessary as there was a lack of documentation of prior data for comparison. Charts of residents identified through the infection control department and communication with nursing staff as having an IUC were reviewed for a 10 month period prior to the implementation of the protocol. A structured data collection sheet was used to record the documented order, indication for use, and care maintenance strategies. Following implementation of the protocol, chart review was conducted prospectively on a monthly basis for six months of residents identified as having an IUC. The data collected were the same as for the retrospective review. Data were entered into a SPSS version 17 database. Frequencies and distributions were analyzed. Rates of IUC use were calculated based on bed occupancy rate for each facility and number of months of data collection. The rate of CAUTIs was calculated based on the number of IUC at each facility. Setting. Two SNF in a Midwest metropolitan area served as settings for implementation of the FIRM protocol. The size of the facilities ranged from 135 to 164 beds with an average daily census of approx- imately 100 long term care residents and transitional care census of 38 and 46.5 residents respectively. Refer to Table 1 for facility char- acteristics. Table 1: Characteristics of the facilities Facility Characteristics Facility 1 Facility 2 Profit/Nonprofit Nonprofit Profit Total Beds 135 164 Skilled 135* 164* Average daily census of skilled res- idents 38 46.5 Average daily census of non-skilled residents 103 104 Total admissions (Jan-June 2009) 192 472 *dual certified Results During the six month chart review following implementation of the protocol, 68 residents had an IUC for a rate of 11.3 IUC per month. The length of time the catheter was in place ranged from 1 to 330 days, with only three residents having an IUC for three days or less. Over two thirds of the IUC were in place for over 30 days indicating long term use. Sixty seven of the 68 (99.5%) catheters had a documented reason that met an acceptable criterion. The retrospective chart review conducted for comparison pur- poses proved difficult. Even though a list of residents were identified as having an IUC, a search of their record many times proved unsuc- cessful in locating an order for the IUC, an indication for an order, a removal order, occurrence of a CAUTI or documentation of any care management strategies. For those with documented orders the retro- spective review identified 52 residents of the SNF who had IUC over the 10 months (5.4/month) prior to the implementation of the FIRM Protocol. A rationale for IUC use was documented for only 37 of the 52 (69%) catheters placed. It is important to note that care maintenance strategies, even though essential for prevention of complications of IUC, were not recorded either prior to implementation or following implementation of the protocol. These care strategies were indicated by the nurses as being completed but not documented. These findings indicate the need to have a specific order for each care strategy is essential if doc- umentation is going to occur. Discussion The monthly rate of IUC use based on bed size indicated that 11.3% of the residents had an IUC following implementation of the protocol.. This rate is slightly lower than the admission rate reported by Rogers et al. (1) and of that found at the Department of Veterans Affairs (DVA) nursing homes (2). Rogers et al. (1) reported that upon admission the prevalence of IUC was 12.6% and that it decreased to 4.5% at the annual MDS review. Within nursing homes in the DVA system, 14% of residents were reported to have an IUC (2). The rate of IUC has decreased steadily since the implementation of CMS re- quirement tag F315 and this may be reflected in the lower rate of IUC use as the previous studies were conducted over three years earlier. The lack of attention to the removal of IUC, especially when an indication was not provided, is of concern. A number of residents were admitted to the facility from an acute care setting with an IUC in place, with little or no documentation of when the IUC was in- serted or a rationale for the placement. Without implementation of the FIRMS protocol the same situation would be allowed to continue and increased untoward effects of the IUC would needlessly occur. The FIRM protocol incorporated elements that were evidence based as well as considered essential by CMS in reducing the use of IUC use among long term care residents. The order sheet pro- vided a quick check to document IUC use. Attaining almost 100% documentation of rationale for catheter use resulted from implemen- tation of the protocol and efforts of the inter-professional team. The collaboration of staff nurses and providers in recognizing the need to document rationale for IUC use contributed to this outcome. Educa- tion of licensed nurses and providers (MD and NP) increased their awareness of the potential inappropriate use of IUC as well as the evidence for management of IUC. Several limitations contribute to the results of the study. The results of the study were contrary to the intent of the protocol im- plementation with an increase in the number of IUC documented. One factor attributing to these results is the increased awareness and attention to the documentation of IUCs by the nurses following the education program. The routine presence of the data collectors on the units doing the chart review may have contributed to use of the FIRMS and improved documentation of IUCs. The method of the study is recognized as a limitation of the study. The retrospective chart review proved challenging for several rea- sons. First the identification of those residents who had IUC over the past ten months was difficult. Various methods for identification of residents retrospectively were used including the infection control list and informal lists kept by the nursing staff. During the process of the retrospective chart review the lack of identification of residents who were admitted from another setting with an IUC in place was recognized. Documentation of the insertion and removal of IUC was difficult to identify in the paper charts as was the occurrence of a Gokula et al. UTJMS 2014 Vol. 1 11 CAUTI and related treatment. As only code numbers were used to record data, the residents who were in the facility prior to and during implementation of the project were included in both samples; thus the increase in length of time the IUC was in place subsequently in- creased. It was also noted that during the period of implementation the facilities increased the number of residents at a higher level of acuity. The increased acuity potentially contributed as residents were transferred from the hospital for recovery and rehabilitation without the discontinuation of an IUC they already had in place. One important aspect of the FIRM protocol is the maintenance IUC care. The implementation of this aspect of the protocol was un- able to be evaluated as there was no documentation available of this level of care. Recommendation. The implementation of the FIRM protocol as an systemic approach was successful in increasing the staff awareness of the need for a documented order for an IUC. The orders with ra- tionale for use of IUC reached over 99% following implementation of the protocol. This is the first step in ensuring the appropriate use of an IUC. Implementation of a policy to address the problem of inappro- priate use of IUCs in SNF would include the following essential el- ements: a) an order set that addresses rationale for placement, re- moval, and maintenance care, b) a documentation process of mainte- nance care, and c) an assessment process of those with IUC on admis- sion to the facility to determine if use is appropriate. In addition to the policy, the appointment of a nurse champion for ensuring the im- plementation of the policy is critical. The development of electronic health records in SNF has potential to facilitate implementation of the policy with triggered drop down menu prompts. A review of the surveillance for IUC use and CAUTIs is advocated to ensure adher- ence to the policy. This study provides the basis for revisions to the protocol to facilitate further testing of implementation of the FIRM protocol in SNFs. The knowledge gained in implementation of the protocol as well as the method of data collection was incorporated into a currently funded study. Conclusion. Inappropriate use of IUC contributes to serious eco- nomic and quality of care issues and needs to be addressed. The FIRM protocol can serve as one example of a systemic approach to guide implementation of best evidence for the use and care of IUC for residents of long term care facilities. Further research to establish the validity of the FIRM protocol in a perspective study design with a control group is in order. 1. Rogers MA, et al. (2008) Use of urinary collection devices in skilled nursing facilities in five states. J Am Geriatr Soc 56(5):854-861. 2. Tsan L, et al. (2010) Nursing home-associated infections in Department of Veterans Affairs community living centers. Am J Infect Control 38(6):461-466. 3. Harrington C, Carrillo H, Mullan J, Swan JH (1998) Nursing facility staffing in the states: the 1991 to 1995 period. Med Care Res Rev 55(3):334-363. 4. Warren JW (1994) Catheter-associated bacteriuria in long-term care facilities. Infect Control Hosp Epidemiol 15(8):557-562. 5. Johnson TM 2nd, Ouslander JG (2006) The newly revised F-Tag 315 and surveyor guidance for urinary incontinence in long-term care. J Am Med Dir Assoc 7(9):594- 600. 6. Newman DK (2006) Urinary incontinence, catheters, and urinary tract infections: an overview of CMS tag F 315. Ostomy Wound Manage 52(12):34-36, 38, 40-44. 7. U.S. Department of Health and Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS) (2005) CMS manual system. www.cms.hhs.gov Retrieved on November 2, 2009. 8. Kunin CM, Douthitt S, Dancing J, Anderson J, Moeschberger M (1992) The asso- ciation between the use of urinary catheters and morbidity and mortality among elderly patients in nursing homes. Am J Epidemiol 135(3):291-301. 9. Rudman D, Hontanosas A, Cohen Z, Mattson DE (1988) Clinical correlates of bac- teremia in a Veterans Administration extended care facility. J Am Geriatr Soc 36(8):726-732. 10. Saint S, Lipsky BA, Goold SD (2002) Indwelling urinary catheters: a one-point re- straint? Ann Intern Med 137(2):125-127. 11. Mody L, Saint S, Galecki A, Chen S, Krein SL (2010) Knowledge of evidence-based urinary catheter care practice recommendations among healthcare workers in nurs- ing homes. J Am Geriatr Soc 58(8):1532-1537. 12. Von Preyss-Friedman SM (2011) Successful foley reduction quality initiative leads to reductions in UTI rate: The Medical director leads the multidisciplinary team. J Am Med Dir Assoc 12(3):B24-B25. 13. Gokula M, et al. (2012). Designing a protocol to reduce catheter-associated urinary tract infections among hospitalized patients. Am J Infect Control 40(10):1002-1004. doi: 10.1016/j.ajic.2011.12.013 ACKNOWLEDGMENTS. The authors gratefully acknowledge funding provided by the AMDA Foundation/Pfizer QI Award, Shafia Rubeen for collection of the data and Dr. Sadik Khuder for supervision of statistical analyses. 12 utdr.utoledo.edu/Translation Gokula et al. http://www.cms.hhs.gov/transmittals/downloads/r8som.pdf Gokula et al. UTJMS | 2014 | Vol. 1 | A1 Appendix  A   FIRMS:  Foley  Insertion,  Removal  and  Maintenance  Sheet   Note:  Protocols  do  not  replace  clinical  judgment  and  should  be  modified  according  to  individual  resident  needs.   INDICATIONS  FOR  INSERTION      Mark  box  for  rationale  for  insertion  and  use:   Absolute  Acute  Indications:     ¨  Obstruction  distal  to  the  bladder.   ¨  Alteration  in  blood  pressure  or  volume  status   ¨  Worsening  renal  failure   ¨  Continuous  bladder  irrigation   ¨  Neurogenic  bladder.   Relative  Indications:   ¨  Morbid  obesity  >400lbs   ¨  Continuous  epidural  anesthesia   ¨  Congenital  urologic  abnormalities.   ¨  Other_______________________   OR   CMS  Justifiable  Indications  beyond  14  Days  (Tag  F315):   □ Urinary  retention  that  could  not  be  otherwise  corrected  and  was  characterized  by  post-­‐void  residual  volumes   greater  than  200  mL   □ Infeasibility  of  intermittent  catheterization  and  persistent  overflow,  symptomatic  infection  or  renal  dysfunction   □ Poorly  healing  Stage  3  or  4  pressure  ulcers  impaired  with  contamination  with  urine   □ Terminal  illness  or  severe  impairment  of  whom  reposition  would  be  uncomfortable  or  painful   Other  indication  not  listed:     If  your  reason  for  urinary  catheter  is  not  listed  in  the  appropriate  indications,  resident  may  not  need  a  urinary  catheter.   Please  reconsider  decision.       REMEMBER:  Catheters  are  one  point  restraints,  longer  it  stays  the  higher  risk  of  infection!     Alternatives  for  Bladder  Management      Mark  box  of  alternative  to  use:     Condom  catheter     Bedside  urinal     Bladder  toileting  program  (TAN)     Prompted  voiding     Dementia  residents:  Check  and  change     strategy                 Intermittent  straight  catheterization(ISC)  briefs     MAINTENANCE  CARE  ORDER   ¨  Systematic  Evidence  Based  Protocol  (SEBP)  to  be  followed  for  initiation,  maintenance  and  removal  of  urinary  catheter   (Refer  to  back  page  for  key  care  maintenance  points  and  to  Policy  and  Procedure  Manual  for  details).         REMOVAL  ORDER:     Remove  catheter  post  insertion  (48  hours)  unless  otherwise  stated  by  physician     Reminder  will  be  placed  in  the  chart  for  Foleys  continued  ≥  48  hours.  The  remainder  will  be  signed  for  continued  use  of   urinary  Catheter       Systematic  Evidence  Based  Protocol  (SEBP)  to  be  followed  for  initiation,  maintenance  and  removal  of  urinary  catheter  (Details   in  Policy  and  Procedure  Manual)     Bladder  ultrasound  protocol  will  be  followed  following  discontinuation  of  the  catheter.  OK  for  nurse  directed  ISC  (Details  in   Policy  and  Procedure  Manual)OR  follow  defined  protocol  developed  by  physician  preference   Physician  Signature     Date  &  Time     Physician  Printed  Name           RN  Signature     Date  &  Time     RN  Printed  Name             Key  Maintenance  Care  Orders  (Refer  to  Policy  and  Procedures  Manual  and  Standards  of  Care  for  Details)   1) Wash  hands  before/after  catheter  care           Gokula et al. UTJMS | 2014 | Vol. 1 | A2   2) Catheter  system  is  a  sterile  environment  and  a  closed  system  needs  to  be  maintained.   i) If  necessary  to  open  the  system  strict  aseptic  technique  needs  to  be  followed.   ii) Use  the  distal  emptying  spout  to  empty  the  drainage  bag.  Avoid  contamination  of  the  distal  emptying  spout  by  preventing   contact  with  any  surface.  Cleanse  the  distal  end  of  the  emptying  spout  with  an  alcohol  wipe  before  reinserting  it  into  the   holder.     iii) Cleanse  the  catheter/drainage  bag  junction  with  an  alcohol  wipe  prior  to  changing  to  the  leg  bag  and/or  drainage  bag.     3) Provide  perineal  catheter  care  every  shift  and  as  needed  (following  any  possible  contamination).    This  is  a  clean  procedure.  Routine   cleaning  of  the  meatal  area  with  antiseptic  solutions  should  be  avoided.     4) Excessive  manipulation  of  the  catheter  is  to  be  avoided.  Motion  of  the  catheter  at  the  urethral  junction  may  increase  the  risk  of   infection.     i) Anchor  the  catheter  to  the  resident’s  thigh.  Anchor  the  suprapubic  catheter  to  the  abdomen.     (i) Allow  slack  on  the  catheter  between  the  meatus  and  the  tape.     (ii) Change  the  anchoring  site  daily  to  prevent  skin  breakdown.     (iii) If  desired,  a  Foley  catheter  leg  strap  holder  can  be  used  to  anchor  the  catheter.  The  leg  strap  site  should   also  be  changed  daily  -­‐  alternate  legs.       5) Position  the  drainage  bag  below  the  level  of  the  bladder.  Assure  that  there  are  no  kinks  or  dependent  loops  in  the  tubing.  Attach  the   drainage  bag  to  the  bed,  NOT  the  side  rail.     6) Check  that  urine  flow  in  the  tube  is  unobstructed  on  routine  basis.       7) Collection  of  urine:   i) Small  sample  -­‐Collect  from  the  sample  port  with  a  sterile  needle  and  syringe  after  cleansing  the  port  with  disinfectant.   Send  the  urine  specimens  for  culture  to  the  lab  promptly.   ii) Larger  sample  -­‐Collect  from  drainage  bag  for  special  analyses  using  aseptic  technique.     8) Use  separate  container  for  each  resident  to  drain  the  collecting  bag.  Do  not  touch  the  draining  spigot  to  the  collecting  container       9) Cross  infection  can  be  minimized  by  clustering  residents  with  urinary  catheter  associated  infections       10) Monitor  for  Signs/Symptoms  of  UTI  routinely:   New  onset  Flank  pain   Fever >100.3° F Rigors Hypertension Change of Condition Delirium Recent catheter obstruction     11) Use  Bladder  Ultrasound  Protocol  following  removal  of  catheter:   i) Initiate  bladder  ultrasound  protocol  if  resident  has  not  voided  4-­‐6  hours  after  catheter  removal   (a) If  ultrasound  urine  volume  is  less  than  250  ml  reassess  in  2  hours     (b) If  ultrasound  volume  >250  encourage  to  void  into  a  bedpan  or  lavatory     1. Measure  voiding  volume  and  record     (c) If  not  able  to  void  and     1. volume  is  <400  ml  continue  observation  for  2  hours     2. volume  >400  ml  perform  intermittent  straight  catheterization  and  record  urine  volume       12) Assess  daily  need  and  obtain  order  for  removal  when  no  longer  needed                   13) Removal  of  catheter     i) Allow  catheter  balloon  to  deflate  passively  without  aspiration.     ii) Do  not  cut  off  the  inflation  port   Remember  to  document  the  care  of  urinary  catheter   FIRM Protocol Methods Setting Results Discussion Recommendation Conclusion