poster presentation final draft
TRANSCRIPT
Using Gap Analysis and USP 797 Guidelines to Improve Outcomes
in Sterile Compounding at University Medical Center South Campus Kathryn Alver1, Megan Handley1, Amanda Zale1, Albert Cortese PharmD2
The University of Arizona College of Pharmacy, PharmD Candidates 20151, UAMC South2
Background and Introduction
Definitions
• Sterile: “free from living germs or microorganisms”1
• Compounding: “any of the following activities occurring in a
licensed pharmacy, by or under the supervision of a licensed
pharmacist, pursuant to a prescription:
* Altering the dosage form or delivery system of a drug
* Altering the strength of a drug
* Combining components or active ingredients
* Preparing a drug product from chemicals or bulk drug
substances”2
• United States Pharmacopeia (USP) 797: “a far-reaching
regulation that governs a wide range of pharmacy policies and
procedures […] designed both to cut down on infections
transmitted to patients through pharmaceutical products and to
better protect staff working in pharmacies in the course of their
exposure to pharmaceuticals”3
Background
• Compounding, cleaning, and sanitizing techniques of University of
Arizona Medical Center (UAMC) South Campus personnel are not
always consistent with USP 797 guidelines.
• Compounding environments and surrounding areas do not meet
all USP 797 requirements.
• Quality of patient care can be improved by increasing knowledge
of, and adherence to USP 797 guidelines.
• Sterile compounding techniques are important because they, "cut
down on infections transmitted to patients through pharmaceutical
products and to better protect staff working in pharmacies in the
course of their exposure to pharmaceuticals.”4
Problem Description
• The practice setting observed included the inpatient pharmacy,
emergency department (ED) and intensive care unit (ICU) at
UAMC South Campus.
• The medication use process involved was medication preparation.
Prior Research
• Gap analyses have been used in hospitals nationwide to measure
adherence to USP797.5
• Pharmacy Purchasing and Products Magazine publishes updates
on USP797 national compliance of hospitals annually. Some
relevant statistics include:
* Gap analysis conducted: 17% within 6 months; 35% 6
months-1 year; 20% 1-2 years; 8% 2-3 years; 8% 3+
years; 12% never
* Patient incidents involving compounding errors: 31%
* Projected timeline to full compliance: 26% within 6
months; 33% 6 months to 1 year; 20% 1-2 years; 10% 2-3
years; 11% no plans for compliance
* Difficulty getting budget approval: 24% very difficult; 23%
difficult; 33% somewhat difficult; 21% not difficult6
Purpose of Project
To decrease the risk of contamination of compounded medications
through identifying non-adherence to USP797 protocol to
ultimately improve patient outcomes.
Objective
• To assess where pitfalls occur in abiding to USP797 guidelines
using garbing guidelines, a gap analysis, and chi-square analysis.
• To use these assessments to improve quality of compounding
techniques at UAMC South Campus, with the goal of not
contributing negatively to patient outcomes.
Methods
• Employees were observed once a week for 3 hours (between
January 2013 to March 2013), and analyzed using a gap
analysis to determine problems in sterile compounding
techniques, when using a flow hood as illustrated in Figure 1.
• Nurses were observed in the ED and ICU for compounding
technique by injecting a vial of normal saline into an intravenous
bag of normal saline.
• A preliminary quiz was administered to the inpatient pharmacy
technicians to determine their understanding of proper garbing
techniques and USP 797 guidelines.
• After the preliminary quiz and observations, the technicians at
UAMC South were provided a PowerPoint presentation in order
to demonstrate correct compounding skills.
• This presentation highlighted the areas of USP797 that needed
to be improved upon, such as questions answered incorrectly
from the quiz, and incorrect technique observed during January
2013 to March 2013.
• After this intervention, the technicians were given another quiz
to assess if their knowledge of USP 797 had indeed improved.
• Independent variable: time of measurement (pre-presentation
and post-presentation).
• Dependent variable: understanding of USP797 guidelines, gap
analysis score, quiz scores.
• Data were analyzed using percentages for the garbing
guidelines (Table 1), chi-square analysis of quiz scores pre- and
post-intervention with an a priori value of 0.05 (Table 2), and
sums for the gap analysis guidelines (Table 3)..
Data
Table 1. Percentage of technicians following USP 797 garbing
guidelines (n=6). Guideline abbreviations below come from
garbing codebook.
Conclusion and Discussion
• If time had allowed, it would have been useful to observe the
technicians compounding technique post-intervention to see if
improvements occurred, or to help them practice correct
technique.
• Further research could include a more comprehensive look at
each individual compounding CSPs, with the use of video
cameras for a longer period of time in order to obtain more data.
• Research could be done by evaluating whether a video of how to
compound CSPs would yield better post-intervention test scores
rather than using the PowerPoint presentation, or if practice
sessions could help yield better compliance.
Recommendations and
Future Research
References
1. Dictionary.com. Sterile. Retrieved at: http://dictionary.reference.com/browse/sterile. Accessed
2013 April 1.
2. Department of Consumer Affairs Board of Pharmacy. Compounding questions and answers.
Retrieved at: http://www.pharmacy.ca.gov/publications/compounding_qa.pdf. Accessed 2013
April 1.
3. USP 797.org. Retrieved at: http://www.usp797.org/index.html. Accessed 2013 April 1.
4. Bernstein, WN. Pharmacy Facts: architectural and environmental changes required for USP
797. In: Health facilities management magazine. July 2005
5. Allen, JV. Gap analysis survey: compounding sterile preparations. In: The international journal
of pharmaceutical compounding. Edmond, OK.
6. Halvorsen, D. Challenge of complete compliance. In: Pharmacy purchasing and products.
Volume 9 number 4. April 2012.
7. Preacher KJ. Calculation for the chi-square test: an interactive calculation tool for chi-square
tests of goodness of fit and independence [Computer software]. 2001. Available from:
http://quantpsy.org.
Results
Limitations
• Being able to gather enough data to assess sterile
compounding techniques of UAMC-South employees because
of time constraints.
• Being able to watch enough employees perform compounding
duties, as opposed to the same employees each week.
• Getting the opportunity to observe each of the criteria needed
on the gap analysis.
• The technicians knowing they were being observed for
technique and being more conscientious of proper
compounding technique (Hawthorn Effect).
• Not having enough nurses to observe. ER (n=3); ICU (n=0).
• Not all technicians turned in a post-intervention quiz.
For more information, please contact:
Kathryn Alver: [email protected]
Megan Handley: [email protected]
Amanda Zale: [email protected]
Albert Cortese: [email protected]
Implications
• Properly compounding sterile products (CSPs) is important
because it yields better patient outcomes.
• Not using the best aseptic technique practices can lead to
infections and worsening of a patient's disease state.
• Hospitals are held to a certain standard by the government
concerning compounding expectations, and lapse in following
these standards could result in negative implications for UAMC
South Campus.
Data Continued
Figure 1. Example of ISO Class 5 HEPA laminar flow hood.
Guideline Technicians
Following
Guideline (%)
Guideline Technicians
Following
Guideline (%)
Clothing 100 Gown 100
Jewelry 33.33 Thumb 0
Food 100 Closure 16.67
Nails 33.33 Gloves 100
Hair 100 Cleanser 100
Demarcation 66.67 Defects 66.67
Shoes 83.33 Isopropyl
alcohol
33.33
Head 83.33 Removal 83.33
Face 100 Hook 100
Hands 0 Discard 100
Towel 16.67 Dirty 83.33
Pre-
Intervention
Post-
Intervention
Total
Answers Right 76 72 148
Answers Wrong 20 0 20
Total 96 72 168
Chi-Square 0.00003685
Table 2. Pre-/post- intervention quiz scores and chi-square
analysis. Eight technicians returned quizzes pre-intervention
and six technicians returned quizzes post-intervention.
Guidelines
Followed
Guidelines Not
Followed*
Guidelines
Unanswered**
Total #
Guidelines
171 80 29 280
Table 3. Guidelines from gap analysis followed or not followed by
UAMC South Campus Inpatient Pharmacy.
• This project used a purposive sample of pharmacy technicians
and nurses.
• Of the 22 total garbing guidelines, 13 were followed less than
100% of the time (Table 1).
• Post-intervention data revealed that zero questions were
answered wrong after administration of the PowerPoint
highlighting areas of USP797 that needed improvement, such as
proper garbing technique (Table 2).
• Chi-square analysis showed a significant difference between the
pre- and post- intervention groups evaluating knowledge of
USP797; p = 0.00003685 (Table 2).
• In regards to Table 3, 11 of the guidelines not followed came from
the “cleaning and disinfecting the compounding area” section of
the gap analysis (total of 16 guidelines in that particular section).
• Pre-intervention, there were a number of garbing guidelines
followed less than 100% of the time, showing a need for
improvement in sterile compounding technique (Table 1).
• According to the chi-square analysis, there was a statistically
significant decrease of incorrect answers in the post-intervention
quiz compared to the pre-intervention quiz (Table 2).
• Improvement can be addressed by first identifying problem areas
within garbing procedure and providing technician staff with
correct procedures tailored to those problems.
• We hope that by providing technician staff with a PowerPoint
presentation identifying non-adherence to USP797 protocol may
help the technicians’ adherence and decrease the risk of
contamination of compounded medications, ultimately improving
patient outcomes.
• Additionally, UMC South still has areas in the USP 797 gap
analysis (mostly in policy and properly cleaning and disinfecting
work areas) in order to adhere to its guidelines completely (Table
3).
* Guidelines not followed 100% of the time
** Guidelines unanswered were unable to be observed due to insufficient time allotted or
guidelines not yet added into inpatient pharmacy policy