methods results discussion & conclusions ...

FOCUS ON QUALITY CARE AN AUDIT OF SURGICAL SKIN PREP PRACTICES IN U.S. HOSPITALS AUTHORS: Hugo Xi, BM, MS, MBA; Gina Parsons, BS, BBA; Lena Pearson RN, BSN, MS, CNOR. CareFusion, Vernon Hills, IL.

INTRODUCTION Each year in the United States, 1.7 million patients develop a healthcare-associated infection (HAI),1 and nearly 100,000 die from one.2 In total, annual costs for the 5 major HAIs was $9.8 billion, with surgical site infections (SSIs) contributing the most to overall costs (33.7% of the total).3 The Patient Protection and Affordable Care Act will place up to 9.5% of Centers for Medicare and Medicaid Services (CMS) payments “at risk” for hospitals in fiscal year 2017.4 Recent studies demonstrate that evidence-based interventions can substantially reduce the incidence of HAIs, and that at least 50% are preventable.5,6 Thus, HAIs represent a key opportunity to save lives and reduce costs. Many intervention initiatives such as Surgical Check List, SCIP, JOINT and CUPS have demonstrated that standardized processes can substantially and successfully reduce the incidence of HAIs.7,8 Clinicians increasingly recognize that interventions, including process steps with a specific goal of reducing variation between surgeons, result in more positive outcomes.9 The “Focus on Quality Care Program” (FQCP) is a service designed to help hospitals reduce or eliminate variability in processes and have less waste, fewer errors and better outcomes. The program includes identification of evidence-based best practices, an action plan, training, support tools, and product portfolio optimization. One area of focus is surgical care, and includes assessment of surgical prepping procedures and comparison to practice standards.10 The program includes use of a proprietary, automated IPAD-based operating room (OR) Audit Tool, which helps ensure consistency and standardize data collection from audits across hospitals. This study reports aggregate findings from FQCP observations of surgical skin prepping procedures in a sample of hospitals in the United States.

RESULTS During the 6-month period from August 21, 2013 to February 21, 2014, 100 hospitals were enrolled in the audit program. The hospitals were distributed geographically across the United States (Fig 1), and ranged from small community hospitals to large academic centers of excellence.

To our knowledge, this is the first report of levels of compliance with standard surgical skin preparation procedures across U.S. hospitals widely varying in size and geographic distribution. Our findings suggest that current guidelines and product directions for surgical skin preparations are not followed in a significant proportion of hospitals, with considerable variability within and between hospitals and across different types of products. Specifically, our findings show:

There were a total of 775 observations of various procedures. The proportions of observations across major types of surgical procedures are shown in Fig 2. Two-thirds of the observations were of general, lower bone and joint, and female reproductive surgeries. The data show that departures from standard prepping procedures occur often, as indicated by the percent of total observations. For example, adequate skin prepping time and drying time – based on FDA-approved product label directions – were used only 60% and 53% of the time, respectively. Gloves were used 91% of the time. Antiseptic skin preps were applied according to FDA-approved label directions only 63% of the time, and were applied at the incision site and out from it 86% of the time (Fig 3). There was high variability in skin prep application methods used across the types of products. Application method compliance with label directions was generally lowest (44%) among older, traditional products, i.e., those available on the market for a long time, including PVP Paint or Scrub or Gel preparations. Compliance was higher with povidone- and alcohol-containing agents and chlorhexidine gluconate (CHG) preps (82% and 65%, respectively) (Table 1). The data also suggest compliance was greater with one-step than with two-step combination preparations (69% vs. 60%, respectively) (Table 2). Eyes, ears, mouth (1%)

Male reproductive (2%)

Figure 3: Overview of skin prep procedure compliance

Plastic

4%

60%

Neurologic/CNS

Adequate skin prep drying time used

7%

General surgery

35%

Cardiovascular

Figure 2: Percent of total (775) observations across surgical categories

8%

Lower bone/joint

22%

53%

Skin prep application beginning at surgical/incision site and out to periphery

86%

0

20

Cincinnati, OH Cleveland, OH Columbus, OH Conyers, GA Dallas, TX (2) Dayton, OH (2) Durham, NC Easley, SC Flemington, NJ Forest Hills, NY Fort Jackson, SC Fort Worth, TX (2) Gainesville, GA

Glen Cove, NY Grand Rapids, MN Green Bay, WI Greenfield, IN Hialeah, FL Huntington, NY Huntsville, AL (2) Indianapolis, IN Jacksonville, FL (2) Kissimmee, FL La Crosse, WI Lakeland, FL Manhasset, NY (2)

Marietta, OH Melbourne, FL Meridian, MS Modesto, CA Monroe, LA Monroe, WI Morgantown, WV Mount Vernon, IL Nashville, IL Neenah, WI (2) New Florence, MO New Hyde Park, NY (2) New York, NY (2)

40

60

PERCENT OF OBSERVATIONS

Newport News, VA Ocean Springs, MS Ogden, UT Omaha, NE Orlando, FL Overland Park, KS Pasadena, CA Pascagoula, MS Phoenix, AZ Pikeville, KY Plainview, NY Pompano Beach, FL Redwood City, CA

Rochester, NY Saint Louis, MO Salt Lake City, UT (2) San Antonio, TX San Diego, CA Savannah, GA Sharon, PA Sherman, TX Sikeston, MO South Miami, FL Stamford, CT Staten Island, NY Sumter, SC

Syosset, NY Tampa, FL Toledo, OH Turtle Lake, ND Valley Stream, NY Waconia, MN Wausau, WI (2) White Plains, NY Winter Haven, FL Wisconsin Rapids, WI

Table 1: Application method compliance with label direction among skin preps with different active agents Application Method Described in Approved Product Label Directions

Percent of Time Applied Per Labeling Directions

Concentric Circles

44%

(Iodine in Alcohol, e.g., 0.83% iodine/72.5% IPA, 0.7% iodine/74% IPA)

Paint/Coating

82%

CHG-Based (n=531) (2% CHG in 70% Alcohol, Aqueous CHG 2% or 4%)

Back & Forth Friction Strokes or Swabbing

65%

80

Surgical Skin Prep Products (Total # of Observations)

Application Method Described in Approved Product Label Directions

Percent of Time Applied Per Labeling Directions

1-Step Combination Prep (n=564)

Varies (Back & Forth for 2% CHG in 70% Alcohol; Paint/Coating for Iodine in Alcohol)

69%

Concentric Circles

60%

(2% CHG in 70% Alcohol, 0.83% iodine/72.5% IPA or 0.7% iodine/74% IPA)

100

2-Step Combination Prep (n=85)

(PVP Scrub & Paint)

REFERENCES 1 2 3 4 5 6 7 8 9

3 Gloves are not universally worn by clinicians during the application of skin preparations. 4 A significant percent of the time, surgical skin prep solutions are improperly applied. The data also underscore the importance of product education and training. While older, traditional skin prep agents such as PVP Scrub & Paint have been available in the market for over 30 years, application methods with those products were least in compliance with product label directions. This may indicate insufficient training for the use of older, traditional products. The greater clinical efficacy as well as the time savings for 1-step compared to 2-step combination skin preps have been well documented.11 It might also be important to further study the benefits of improving compliance with the label directions for the 1-step combination agents, as it may have a direct and positive impact on the clinical efficacy of those products. Limitations of our study include its use of a non-randomized convenience sample of hospitals, and the audit only assessed procedures, not actual outcomes.

Table 2: Application method compliance with label direction among combination skin preps

63%

12%

Anaheim, CA Antioch, CA Austin, TX Bay Shore, NY Biloxi, MS Boston, MA Bourne, MA Bradenton, FL Broken Arrow, OK Cairo, GA Carmel, IN Charleston, SC Chattanooga, TN (2)

PVP and Alcohol containing agents (n=87)

Skin prep application method followed label directions

Female reproductive

Figure 1: Locations of audited U.S. hospitals

(10% PVP Paint, PVP-I Scrub & Paint, PVP Scrub, Iodine Gel)

91%

10%

2 Many skin preparation procedures are non-compliant with skin prep dry times.

PVP Paint or Scrub or Gel (n=145)

Gloves used

Upper bone/joint

1 Many hospital ORs use inadequate skin prep time.

Surgical Skin Prep Products (Total # of Observations)

Adequate skin prep time used

METHODS A team of observers, including clinical consultants, used the proprietary, automated IPAD-based OR Audit Tool to assess surgical skin prepping procedures. The hospitals enrolled in the audit program are a convenience sample of U.S. hospitals. The observers captured data through interviews with hospital clinical nurses and by monitoring operating room procedures. The audit focused on surgical prep procedures, including antiseptic preparations and application methods used. Data across hospitals were aggregated and analyzed using descriptive statistics.

DISCUSSION & CONCLUSIONS

Yokoe DS, Mermel LA, Anderson DJ, et al. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(suppl 1):S12-S21. Klevens RM, Edwards JR, Richards CL Jr, Horan TC, Gaynes RP, Pollock DA, Cardo DM. Estimating health care associated infections and deaths in U.S. hospitals, 2002. Public Health Rep 2007; 122:160-166. Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. Patient Protection and Affordable Care Act (PPACA) of 2010, Sections 3001, 3008 and 3011. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355(26):2725-2732. Centers for Disease Control and Prevention. Making health care safer: reducing bloodstream infections. http://www.cdc.gov/VitalSigns/pdf/2011-03-vitalsigns.pdf. Accessed September 1, 2012. Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. Bergs J, Hellings J, Cleemput I, Zurel O, De Troyer V, Van Hiel M, Demeere JL, Claeys D, Vandijck D. Systematic review and meta-analysis of the effect of the World Health Organization surgical safety checklist on postoperative complications. Br J Surg. 2014 Feb;101(3):150-8. Cima R, Dankbar E, Lovely J, Pendlimari R, Aronhalt K, Nehring S, Hyke R, Tyndale D, Rogers J, Quast L; Colorectal Surgical Site Infection Reduction Team. Colorectal surgery surgical site infection reduction program: a national surgical quality improvement program--driven multidisciplinary single-institution experience.J Am Coll Surg. 2013 Jan;216(1):23-33. 10 Association of Perioperative Registered Nurses (AORN). Recommended practices for preoperative patient skin antisepsis. In: Standards, Recommended Practices, and Guidelines. Denver, CO: AORN, Inc; 2013:75-90. 11 McDonald C, McGuane S, Thomas J, Hartley S, Robbins S, Roy A, Verlander N, Barbara J. A novel rapid and effective donor arm disinfection method. Transfusion. 2010 Jan;50(1):53-8.

PERIOPERATIVE NURSING IMPLICATIONS Departures from recommended directions for use of skin antiseptics are a significant issue. Perioperative nurses can and should play an important role in monitoring and carrying out processes to improve compliance to standard practices and guidelines. Their efforts in standardization and auditing would improve the consistency of the clinical practice, which can translate to increased efficiencies (e.g., simplified OR carts and fewer SKUs), reduced costs and improved outcomes.