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N628 FMEA Prevention of Surgical Site Infections A Systematic Review in the Pre Surgical Phase Summary Brief

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Title: Submission N628 FMEA (RCA) Summary Brief

Project Type: An adaptation of a failure mode and effect analysis in the healthcare setting relating to pre op interventions for preventing SSI orthopedic infections with total hip/knee surgeries.

Background:

Surgical site infections (SSIs) are one of the most prevalent, and life-threatening, causes of healthcare-associated infections in the United States today. In 1996, it was reported that over 1.5 million SSIs occurred annually based on reports generated from the CDC and National Center for Health Statistics (Sage Products). Since then, according to one source in 2006 alone, an estimated 8% of patients in the hospital setting in the U.S. had developed a healthcare-associated infection, with SSIs accounting for 14% of these infections (U.S. National Library of Medicine, 2008). This statistical finding merely represents the reported SSIs while in the

hospital; which prevalence studies tend to underestimate SSIs because many of these infections occur after the patient has been discharged from hospital.

SSIs can double the length of time a patient stays in the hospital and therefore, increase the overall health care costs accumulated; which is great for insurance providers, but detrimental to the given healthcare organization, as well as the patient. As the CDC states, SSIs jeopardize patient safety at an alarming rate and cost the health care system billions of dollars annually (Horan, et al, 2013). The main additional costs on the patient and healthcare organization are related to re-operation, extra nursing care and interventions, and drug treatment costs, the CDC illustrates. The indirect costs, due to loss of productivity, patient dissatisfaction and litigation, and reduced quality of life are other important factors to consider.

SSIs can in fact, attribute costs as high as $25,546 for just one surgical site infection, based on a review of studies published from 2001 to 2004 (Horan, et al, 2013). For elderly patients, SSIs due to S. aureus led to, on average, 12 additional hospital days, with excess costs of more than $40,000 and for patients with a MRSA SSI, a reported mean hospital charge of $84,020 or higher than those recovering from surgery with no complications (U.S. National Library of Medicine, 2008). In short, uninfected patients have a decreased length of hospital stay following surgery, and therefore, have more remaining rehabilitation days with insurance

companies to increase their likelihood of a successful recovery.

The potential savings of simple pre-op prevention interventions for the healthcare

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guidelines for surgical antimicrobial prophylaxis in the pre-op phase, according to the U.S. Department of Health and Human Services (U.S. Department of Health and Human Services, 2013).

As mentioned, many complications can result from SSIs and are associated with

considerable morbidity with over one-third of postoperative deaths being related, at least in part, to an SSI. Patients who develop SSIs are reportedly twice as likely to die, 60% more likely to spend time in an intensive care unit, and more than five times more likely to be readmitted to the hospital (U.S. National Library of Medicine, 2008). The CDC’s National Nosocomial Infections Surveillance (NNIS) system reported that SSIs are the third most frequently reported nosocomial infection and when surgical patients with nosocomial SSI died, 77% of the deaths were reported to be related to the infection itself (Horan, et al, 2013).

Project Support:

One of the CDC’s recommendation for the prevention of surgical site infections relates to advances in infection control practices which include ensuring the availability of antimicrobial prophylaxis in the pre-op phase (Horan, et al, 2013). According to the CDC, microbial

contamination of the surgical site is a necessary precursor of SSI; therefore, the administration of such prophylactic antimicrobial prior to the scheduled surgery is one recommendation to aid in the elimination of this type of nosocomial infection in the healthcare setting. This

recommendation mentioned above includes the following interventions based on the Institute of Healthcare Improvement recommendation and one of the National Patient Safety Goals

established by the Joint Commission which includes: clinician use of an alcohol-containing antiseptic agent for preoperative skin preparation; patient use of chlorhexidine wipes or soap for three days prior to surgery; and clinician screening and decolonization of Staphylococcus aureus intranasal with mupirocin (The Joint Commission, 2013).

The CDC also advices hospitals performing surgeries to administer antibiotics before surgery and continue for 24 hours after surgery, and also to clean the skin at the site of your surgery with a special soap that kills germs, or in other words, an antimicrobial solution (Horan, et al, 2013). The Joint Commission took action with this national concern and published, since 2010, four National Patient Safety Goals (NPSGs) that focus on health-care associated

infections, with a significant focus on surgical site infections. All four NPSGs specify the evidence-based requirements for preventing or reducing healthcare associated infections with the administration of prophylactic antimicrobial agents for a particular procedure or disease

according to evidence-based practices (The Joint Commission, 2013). Another NPSG

encouraged by the Joint Commission involves implementation of policies and procedures aimed at reducing the risk of surgical site infections that meet regulatory requirements and are aligned with evidence-based guidelines (The Joint Commission, 2013).

Another supporter of this preventative approach is through The U.S. Department of Health and Human Services. This organization publicly promotes the benefits of the

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lastly, reducing the duration and cost of health care. (U.S. Department of Health and Human Services, 2013). A study was also conducted and released to determine the effectiveness of administering such agents, utilizing a scoring system based on 3 categories to include category A, B, & C; all of which provided evidence that supports the use of antimicrobial prophylaxis with a diverse group of medical procedures (U.S. Department of Health and Human Services, 2013).

Current Status related to processes, patterns and professionals:

Professionals: The professionals in this microsystem and that are involved with the implementation of these new standardized pre-op interventions include the RNs, LVNs, Associate Directors of Nursing, Director of Nursing, quality improvement manager, central supply coordinator, pharmacy representatives, and lastly, the primary physicians as well as the practicing orthopedic surgeons. Each team member has a specific role to patient care in the pre-operatory phase and their involvement and roles largely contribute to patient care outcomes and whether these outcomes are successful in meeting the target aim and goals of the microsystem. The CNL’s role as an outcomes manager and the implementation of this new process is to focus on the reduction of adverse effects to increase the likelihood of positive patient outcomes through this FMEA approach. The CNL and quality improvements representative played a large role in the incorporation of this new care process as well as the implementation of the FMEA. The quality improvement coordinator will be evaluating the effectiveness of the new pre-op process and including this in the final evaluation of the FMEA be the end of April. Processes: Through a systems analysis approach and data collection process, the team was able to review the new standardized prevention interventions in the pre-op phase to further identify a few areas of improvements, and ensure the success of the implementation of such care processes. The data was organized through a check list that was created for review, interviews that were conducted with staff, and through the coordination of a focus group in the initial meeting. The final

evaluation phase has yet to be completed, but is scheduled for completion by the end of April. In this evaluation, an outcomes evaluation process will be completed to compare baseline data to new data to ensure the effectiveness of this new quality improvement measure. Patterns: A review of this microsystem’s new preventative process was analyzed through a FMEA approach to identify any potential failures prior to the start of such changes to ensure patients are receiving high quality and safe patient care. The purpose of reviewing such patterns that were recently created, was to check for potential failure modes and to ultimately decrease the risk of SSIs from orthopedic surgeries that are so frequently performed.

Financial considerations:

Through the analysis of the FMEA and data collection process by the quality

improvements representative, a comparison will be completed of initial costs of SSIs in this microsystem to the costs accumulated by the implementation of this new pre-op process. Information will be compared to ensure financial gain has been achieved and wastes have been eliminated. Aspects that will be evaluated to review costs and savings include the following: savings of prolonged stay at facility; costs of antimicrobial solutions, IV antibiotics,

chlorhexidine wipes, and cost of MRSA nasal swabs; and lastly, staff education and training.

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The creation of the new pre-op standardized care process has been completed, implemented, and will be evaluated by the end of the month. This evaluation that will be

completed by the quality improvements coordinator will include statistical comparisons of initial baseline information, to the new data that has yet to be collected and evaluated. Once such information is collected, a thorough analysis can be implemented to evaluate whether this new process has yielded the desired outcomes and if a reduction in surgical site infections has been accomplished. The quality improvements representative is presently working with corporate officials to gather such information and a meeting is scheduled for the last Friday of the month of April with the interdisciplinary team for the final evaluation step. With a low risk level and score of 44 on the FMEA analysis, the team expects much success with the new pre-op care process and a great reduction in SSIs within the microsystem.

FMEA: Necessity “Process function” Problem: “Failure Mode” Effects: Ho w bad is it? 0-5 Causes: How likel y: Sc ore :

Steps to prevent:

1. Test for SA 1. No swab

available in facility to test

2. No order in place on EMar for nurse to perform procedure. 3. Patient refuses

Pt develops MRSA in incision; lack of nursing

communication

5/5 1. central supply failed to order swabs 2. Electronic health record unavailable; technical malfunction. 3. patient history of

non-compliance

2/5 10 1. Ensure supplies are stocked and ordered. 2. Refer to backup paper documentation and know who to contact when having technical failures. 3. Have doctor come in to explain importance of procedure and

consequences of potential infection. (CHG) soap

for at least three days before surgery

1. Expired medication 2. Allergy to soap 3. Medication unavailable

4. Medication isn’t given x 3 days, only 1 days

1. Local skin reaction may impede surgery 2. local allergy or anaphylactic shock; postpone surgery and patient develops longer stay in facility increasing cost

3. SSI develops from lack of

5/5 1. Nurse failed to check expiration date

2. Nurse failed to verify allergies; patient new allergy unknown 3. Central supply failed to order; medication order failed to be faxed to pharmacy as alternative

2/5 10 1. Create electronic prompt to verify expiration date 2. educate to staff to always verify allergies prior to ANY medication administration

3. verify central supply has ordered one week prior to surgery

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medication 4. SSI develops from improper administration of medication

delivery method 4. Nurse failed to check order; Shift endorsement failed to communicate which day of medication patient was on at end of shift

number of times soap has been administered to prevent error and

increase effective communication

Hair removal 1. No razor available. 2. wasn’t

completed prior to surgery

3. patient shaved with dirty razor 4. Procedure wasn’t carried out effectively; potential alteration in skin integrity prior to surgery

1. Procedure isn’t carried out. 2. Preventive measure wasn’t taken, can delay surgery

3. Risk of infection. 4. Risk of infection.

2/5 1. Central supply didn’t complete order.

2. Nurse forgot to complete

procedure

3. Patient refused to have nurse shave or nurse failed to

communicate to the patient the appropriate guidelines of procedure. 4. Failure of nursing skill

1/5 2 1. Communicate with central supply, especially with weeks of numerous scheduled surgeries to ensure supplies are available.

2. Create effective endorsement

communication tools with nursing staff. 3. Ensure patient

verbalized understanding 4. Nursing skill

validation; No delegation to nurse’s aides!

4. Prophylactic antibiotic administration

1. Patient allergy 2. Medication unavailable 3. Wrong medication given 1. Potential anaphylactic reaction; surgery delayed 2. surgery delayed 3. allergic reaction; surgery postponed; medication ineffective in prevention: infection results

5/5 1. Nurse failed to verify allergies; unidentified allergy exists 2. Telephone order was never carried through from doctor by nurse; unavailable from pharmacy; electronic

communication to pharmacy failed 3. Nurse failed to verify right medication

4/5 20 1. Ensure nursing staff always verifies allergies; possibly a new prompt to verify on the electronic EMar the pt.’s allergies prior to administration; provide continuous skill validation on medication administration.

2. Educate to nursing staff proper policy when medication is

unavailable, such as the notification to the doctor for an alternative

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3. Provide medication administration education with skill validation. Monitor vital

signs x 3days prior

1. Wasn’t completed

2. Nurse failed to communicate fluctuations from baseline to MD prior

3. Equipment malfunction

1. Vital sign monitoring was delayed

2. Potential change in patient status that wasn’t communicated to MD, leading to possible sentinel event related to surgery

3. Invalid results

1/5 1. Nurse forgot to delegate task to nurse aid

2. Nurse unaware of significance of alteration in vital signs

3. Equipment wasn’t checked to make sure it was working prior to start

2/5 2 1. Have nurse aids and nurses receive

endorsements so all team members are aware of plan of care

2. Education to staff on significance of vital signs and importance of notifying MD of any changes from baseline. 3. Require equipment checks Q shift

Total Risk Low 44

References

American Association of Colleges of Nursing. (2007). White Paper on the Education and Role of the Clinical Nurse Leader. Retrieved from:

http://www.cnlassociation.org/pdf/ClinicalNurseLeader.pdf

Horan, T., Jarvis, W., Mangram, A., Pearson, M., & Silver, L. (1999). Infection Control and Hospital Epidemiology. Guideline for Prevention of Surgical Site Infection. 20:4. Retrieved from: http://www.cdc.gov/hicpac/pdf/guidelines/SSI_1999.pdf

Sage Products. What the Experts Say: Prevalence, Mortality and Attributable Costs of Surgical Site Infections. Retrieved from:

http://www.sageproducts.com/documents/pdf/education/studies_articles/ssi/

20777_What_The_Experts_Say_Prevalence_Mortality_and_Attributablable_Costs_of_Surgical_ Site_Infections.pdf

The Institute for Healthcare Improvements. (2015). Failure Modes and Effects Analysis (FMEA) Tool. Retrieved from:

http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx

The Institute for Healthcare Improvements. (2012). How-to Guide: Prevent Surgical Site Infections. Retrieved

from:http://www.nhfca.org/psf/resources/SurgicalSafety/HowtoGuidePreventSSI.pdf

Institute for Healthcare Improvement. (2014). How-to Guide: Prevent Surgical Site Infection for Hip and Knee Arthroplasty. Retrieved from:

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The Joint Commission. (2013). The Joint Commission’s Implementation Guide for NPSG.07.05.01 on Surgical Site Infections: The SSI Change Project. Retrieved from: http://www.jointcommission.org/assets/1/18/Implementation_Guide_for_NPSG_SSI.pdf

U.S. Department of Health and Human Services. (2013). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Retrieved from: http://www.guideline.gov/content.aspx? id=39533

U.S. National Library of Medicine. (2008). Surgical Site Infection Prevention and Treatment of Surgical Site Infection. Retrieved from:

References

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