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262
Fig. 15.23 UV disinfection equipment
J.T. Nomura and A.D. Nagdev
Newer ultraviolet light based HLD cleaning systems (Fig.15.23) may become more commonplace soon [33]. They employ short wave UVC light in the 100–280nm range, have short (2–10min) cleaning cycle, and provide HLD.These and other tech­nological advances will allow clinicians a less cumbersome option for HLD, while maintaining patient safety. Emerging data will allow clinicians greater options for high-level disinfection, but current standards still recommend conventional practices.

Critical Devices

Critical devices are those that enter a sterile tissue or vasculature, and require steril­ization. These items include surgical instruments and implantable cardiac devices. Clinicians performing POC US will most commonly not be working with medical devices that require critical sterilization.

Other Ultrasound Machine Elements

Careful attention should be paid to manufacturer instructions on cleaning of key­boards, machine, surface, probe holders, and monitors. While some germicidal sprays may be used on the plastic surfaces, other areas may be permanently dam­aged by strong chemicals in the spray or wipe. However, probe holders in particular should be cleaned as they accumulate dried gel and possibly bodily uids.
15 Ultrasound Safety andInfection Control
263
Ultrasound Gel asaSafety Issue
While US gel is discussed extensively in Chap. 14 (link), a brief discussion of ultra­sound gel safety practices is synergistic with the safety issues with probe cleaning. Ultrasound gel is water-based, and has been episodically associated with nosoco­mial infections [35, 36]. Recently the issue of when sterile US gel should be used versus non-sterile gel has been explored by regulatory bodies [3739].
POC US directors should consider creating policies for safe use of non-sterile ultrasound gel (disposable bottles (Fig.15.24) or lling from large US reservoirs with careful attention to lack of contact of the respective container openings), and policies for use of sterile gel. Sterile gel (Fig.15.25) should be considered for all
Fig. 15.24 Prelled bottles of US gel
Fig. 15.25 Sterile lubricating gel packet
264
invasive procedures (external to the probe cover), US examinations on neonates, US examinations on non-intact skin or fresh surgical sites, endocavitary or endoscopic US procedures on internal mucous membranes, and other examinations of concern. Non-sterile gel can be used for other ultrasound examinations so long the gel is maintained per infection control guidelines. Gel warmers should only use dry heat and be serviced per infection control policies of the institution.
J.T. Nomura and A.D. Nagdev

Summary

Bioeffects are possible with the use of diagnostic ultrasound and are related to a com­plex interplay of the tissues insonated, frequency, intensity, scanning mode, and dwell time. Some of these parameters are under operator control. To adhere to the ALARA principle, operators should be aware of and monitor ultrasound exposure as indicated by the Thermal and Mechanical Indices. The concept of ultrasound bioeffects is only one part of the risk-benet analysis in the emergent setting where the lack of informa­tion presents a clear danger to the patient and impacts clinical management.
Transducer maintenance should be a priority for all clinicians to ensure patient safety. System upkeep involves fastidious cleaning for both the transducer and ultrasound system. A clear departmental infection control protocol will ensure patient safety, as well as detect early breaks in transducer surface integrity. When performing examinations on intact non-mucosal surfaces, low-level disinfection and use of non-sterile gel is adequate. When performing an ultrasound examina­tion on non- intact skin we recommend using a transparent dressing cover over the transducer. For endocavitary examinations, transesophageal echocardiogra­phy, or internal examinations, use of sterile gel on the exterior of the probe and high-level disinfection is mandatory (via either the aide of hospital based sterile processing or an internal highly organized departmental system). Guidelines from transducer manufacturers in conjunction with the CDC can help dene cur­rent standards for HLD. Clinical sonographers should be knowledgeable in regard to current disinfection and sterilization procedures to ensure infection control and patient safety.

Pitfalls

1. Nonadherence to the ALARA principle.
2. Increasing the power output of an ultrasound system from manufacturer presets
without understanding the ODS and potential bioeffects.
3. Not utilizing the correct application preset with appropriate power, TI, and MI
for an examination.
4. Not having a standard protocol for both noninvasive and invasive probes.
15 Ultrasound Safety andInfection Control
265
5. Not having cleaning supplies on the machine or near the machine for POC use.
6. Not having provider and POC friendly logistics for invasive probe care.
7. Not setting responsibilities and accountability for machine and probe care.
8. Not having policies for use of non-sterile and sterile gel.

Key Recommendations

1. Identify, understand, and educate users about the ODS on your ultrasound
system.
2. Monitor and correct inappropriate use of MI and TI settings such as not utilizing
ocular presets on ocular ultrasound or spectral Doppler for fetal heart rate measurements.
3. Create and provide cleaning protocols, logistics, and supplies for POC use.
4. When performing ultrasound examination on non-intact skin, cover the trans-
ducer with a clear adhesive dressing.
5. To ensure patient safety, a clearly dened process of HLD must be in place for
endocavitary and TEE transducer cleaning.
Acknowledgment Dr. J.Brian Fowlkes for his assistance with reviewing and editing the bioef­fects data.
Dr. Andreas Dewitz for his donation of gures for the chapter.

References

1. Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011;364(8):749–57.
doi:10.1056/NEJMra0909487.
2. Nelson TR, Fowlkes JB, Abramowicz JS, Church CC.Ultrasound biosafety considerations for
the practicing sonographer and sonologist. JUltrasound Med. 2009;28:139–50.
3. Cibull SL, Harris GR, Nell DM. Trends in diagnostic ultrasound acoustic output from data
reported to the US food and drug administration for device indications that include fetal appli­cations. JUltrasound Med. 2013;32(11):1921–32. doi:10.7863/ultra.32.11.1921.
4. United States Food and Drugs Administration. Guidance for Industry and FDA Staff—
Information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. 2012.
5. Lee W, Garra B, American Institute of Ultrasound in Medicine. AIUM technical bulletin. How
to interpret the ultrasound output display standard for higher acoustic output diagnostic ultra­sound devices: version 2. JUltrasound Med. 2004;23(5):723–6.
6. National Electronics Manufacturers Association, American Institute of Ultrasound in
Medicine. Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment, Revision 2. January 9AD:1–55.
7. American Institute of Ultrasound in Medicine. Medical ultrasound safety. 3rd ed. American
Institute of Ultrasound in Medicine; 2014, pp.1–61.
8. OBrien WD, Deng CX, Harris GR, etal. The risk of exposure to diagnostic ultrasound in post-
natal subjects thermal effects. JUltrasound Med. 2008;27:517–35.
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9. Abramowicz JS, Barnett SB, Duck FA, Edmonds PD, Hynynen KH, Ziskin MC.Fetal thermal
effects of diagnostic ultrasound. JUltrasound Med. 2008;27:541–59.
10. Mr T, Vedmedovska N, Merialdi M, etal. Safety of ultrasonography in pregnancy WHO system-
atic review of the literature and meta analysis. Ultrasound Obstet Gynecol. 2009;33:599–608.
11. Church CC, Carstensen EL, Nyborg WL, Carson PL, Frizzell LA, Bailey MR.Nonthermal
mechanisms the risk of exposure to diagnostic ultrasound in postnatal subjects. JUltrasound Med. 2008;27:565–92.
12. Stratmeyer ME, Greenleaf JF, Dalecki D, Salvesen KA.Fetal ultrasound mechanical effects.
JUltrasound Med. 2008;27:597–605.
13. Sheiner E, Abramowicz JS.Clinical end users worldwide show poor knowledge regarding
safety issues of ultrasound during pregnancy. JUltrasound Med. 2008;27:488–501.
14. Bagley J, Thomas K, DiGiacinto D. Safety practices of sonographers and their knowl-
edge of the biologic effects of sonography. J Diagn Med Sonography. 2011;27:252–61. doi:10.1177/8756479311424431.
15. Akhtar W, Arain MA, Ali A, etal. Ultrasound biosafety during pregnancy: what do operators
know in the developing world?: national survey ndings from pakistan. JUltrasound Med. 2011;30(7):981–5.
16. Houston LE, Allsworth J, Macones GA.Ultrasound is safe… right?: resident and maternal-
fetal medicine fellow knowledge regarding obstetric ultrasound safety. J Ultrasound Med. 2011;30(1):21–7.
17. World Federation of Ultrasond in Medicine and Biology. WFUMB/ISUOG statement on the
safe use of doppler ultrasound during 11–14 week scans (or earlier in pregnancy). Ultrasound Med Biol. 2013;39(3):373. doi:10.1016/j.ultrasmedbio.2012.11.025.
18. American Institute of Ultrasound in Medicine. Statement on measurement of fetal heart rate.
2011:1–1. http://www.aium.org/ofcialStatements/43.
19. Vrablik ME, Snead GR, Minnigan HJ, Kirschner JM, Emmett TW, Seupaul RA.The diag-
nostic accuracy of bedside ocular ultrasonography for the diagnosis of retinal detachment: a systematic review and meta-analysis. Ann Emerg Med. 2015;65(2):199–203.e1. doi:10.1016/j.
annemergmed.2014.02.020.
20. Lichtenstein D. Lung ultrasound in acute respiratory failure an introduction to the BLUE-
protocol. Minerva Anestesiol. 2009;75(5):313–7.
21. Meltzer RS, Adsumelli R, Risher WH, etal. Lack of lung hemorrhage in humans after intraop-
erative transesophageal echocardiography with ultrasound exposure conditions similar to those causing lung hemorrhage in laboratory animals. JAm Soc Echocardiogr. 1998;11(1):57–60.
22. American Institute of Ultrasound in Medicine. Conclusions regarding epidemiology for
obstetric ultrasound. 2010:1–1. http://www.aium.org/ofcialStatements/16.
23. American College of Emergency Physicians. Emergency ultrasound guidelines. Ann Emerg
Med. 2009;53(4):550–70. doi:10.1016/j.annemergmed.2008.12.013.
24. American College of Emergency Physicians Guidance for Line Model US Scanning in
Educational and conference settings http://www.acep.org/ultrasound-section-microsite/guidance
for live models-us-scanning in educational-end-conference settings. Accessed 30 July 2017.
25. Guideline for disinfection and sterilization in healthcare facilities, 2008. 2015;1–4.
26. AIUM Cleaning Guidelines 2014. 2015. pp.1–5.
27. Guideline for disinfection and sterilization in healthcare facilities, 2008. 2010;1–158.
28. Rooks VJ, Yancey MK, Elg SA, Brueske L. Comparison of probe sheaths for endovaginal
sonography. Obstet Gynecol. 1996 Jan;87(1):27–9.
29. Hignett M, Claman P.High rates of perforation are found in endovaginal ultrasound probe cov-
ers before and after oocyte retrieval for invitro fertilizationembryo transfer. JAssist Reprod Genet. 1995 Oct;12(9):606–9.
30. Fritz S, Hust MH, Ochs C, Gratwohl I, Staiger M, Braun B. Use of a latex cover sheath for
transesophageal echocardiography (TEE) instead of regular disinfection of the echoscope? Clin Cardiol. 1993 Oct;16(10):737–40.
J.T. Nomura and A.D. Nagdev
15 Ultrasound Safety andInfection Control
31. Casalegno J-S, Le Bail CK, Eibach D, Valdeyron M-L, Lamblin G, Jacquemoud H, etal. High
risk HPV contamination of endocavity vaginal ultrasound probes: an underestimated route of nosocomial infection? PLoS One. 2012;7(10):e48137.
32. M’Zali F, Bounizra C, Leroy S, Mekki Y, Quentin-Noury C, Kann M.Persistence of micro-
bial contamination on transvaginal ultrasound probes despite low-level disinfection procedure. PLoS One. 2014;9(4):e93368.
33. Kac G, Podglajen I, Si Mohamed A, Rodi A, Grataloup C, Meyer G.Evaluation of ultraviolet
C for disinfection of endocavitary ultrasound transducers persistently contaminated despite probe covers. Infect Control Hosp Epidemiol. 2010;31(2):165–70.
34. Frazee BW, Fahimi J, Lambert L, Nagdev A.Emergency department ultrasonographic probe
contaminationand experimental model of probe disinfection. YMEM. American College of Emergency Physicians; 2011;1–8.
35. Muradali D, Gold WL, Phillips A, Wilson S.Can ultrasound probes and coupling gel be a
source of nosocomial infection in patients undergoing sonography? An invivo and invitro study. AJR. 1995;164(6):1521–4.
36. O’Rourke M, Levan P, Khan T.Current use of ultrasound transmission gel for transesophageal
echocardiogram examinations: a survey of cardiothoracic anesthesiology fellowship directors. JCardiothorac Vasc Anesth. 2014;28(5):1208–10.
37. Safety Communication: Bacteria found in other-sonic generic ultrasound transmission gel
poses risk of infection. Clinician Outreach and Communication Activity (COCA). CDC Emergency communication System. April 20, 2012. Accessed 5 Jan 2017 http://emergency.
cdc.gov/coca/reminders/2012/pdf/ClinicalReminder_UltraSoundGel_04_20_2012.pdf.
38. Serious risk of infection from ultrasound and medical gels—revision. Health Canada.
December 14, 2004. Accessed 5 Jan 2017 http://www.healthycanadians.gc.ca/recall-alert-
rappel-avis/hc-sc/2004/14289a-eng.php.
39. American Institute of Ultrasound in Medicine. Guidelines for cleaning and preparing exter-
nal- and internal-use ultrasound probes between patients, safe handling, and use of ultrasound coupling gel http://www.aium.org/ofcialStatements/57. Accessed 31 May 2017.
267
Chapter 16
Ultrasound Quality Improvement
Patrick S. Hunt, Christopher David Wilbert, and Zachary T. Grambos

Objectives

• Dene the purpose of Ultrasound Quality Assurance and Improvement (QI)
• Provide an overview of Ultrasound Quality Assurance and Improvement
• Dene a practical and stepwise process for improvement of ultrasound quality

Introduction

Ultrasound quality assurance and improvement is the engine that drives a successful clinical US program. Every department that uses clinical ultrasound should have an integrated quality assurance and quality improvement plan (QI) [2, 27, 29]. While the details of each QI system may differ from program to program, the primary objectives of the program are to ensure a quality product, facilitate education, improve both provider and departmental performance, and to help satisfy credentialing pathways [2, 27].
P.S. Hunt, MD, MBA (*) Department of Emergency Medicine, Palmetto Health Richland, Columbia, SC, USA e-mail: huntpat@sc.rr.com
C.D. Wilbert, MD • Z.T. Grambos, MD, FAAEM Department of Emergency Medicine, St. Thomas Rutherford/Midtown Hospital, Murfreesboro, TN, USA e-mail: grambos1256@gmail.com
V. S. Tayal et al. (eds.), Ultrasound Program Management,
https://doi.org/10.1007/978-3-319-63143-1_16
269© Springer International Publishing AG 2018
270
P.S. Hunt et al.
It is the US director’s responsibility to develop, monitor, and revise the QI pro­cess [2]. QI programs include the processes as well as the hardware and software that make these processes work. The process your program ultimately uses for QI will depend greatly on the hardware and software system deployed.
The US director’s goals regarding QI are multifaceted. At a minimum they must evaluate images that are submitted to ensure they satisfy the minimum imaging requirements (gain/depth/focus) and conrm the images have been interpreted cor­rectly. The director must also provide appropriate feedback to both develop good practice and change detrimental practice. This can be done at the bedside in real time or at a later time in person or electronically [27].
There are many options for QI systems currently on the market. When clinical ultrasound programs began to develop, QI generally consisted of printed images and logs. However, today there are complete digital solutions that help to integrate the QI system to the workow of the ultrasound program. The system that works best for each institution will vary depending on how robust the program is, the amount of administrative and nancial support, as well as the type of machine and support from IT.As cost for data storage and bandwidth have continued to decrease, options for dynamic video review are now more available than ever. While dynamic video is superior to static images, the increased cost, time and labor must be weighted when determining which method of image review is ideal for each program [2, 15, 27].
Process ofQI
Often the QI process is developed in parallel with the credentialing process. During this process a program should determine how they will handle scans completed by both credentialed and non-credentialed sonographers with regard to QI.While most pro­grams will review all scans by non-credentialed sonographers, programs must also decide on the percentage of cases that will be selected for review from credentialed sonographers. This can be a percentage of completed scans or a xed number of scans per year depending on practice habits and prior training/credentialing for the group [1, 2, 28].
It is to be expected that the QI process will look slightly different for every department. Residency programs can expect a continual process given that new resi­dents start every year and must be trained. In community programs the process may require more work at the outset and then stabilize once all the members of the group have been credentialed. However, there are ve key aspects of QI that should be universal to all settings [2].
1. Images must be obtained and stored for review.
2. The sonographer must document their ndings for each study completed.
3. Images must be reviewed by the QI director and feedback given on both technical
and clinical grounds.
4. Feedback on images must be reviewed by the sonographer.
5. Data on the feedback given and the exams completed must be stored for later
review.
16 Ultrasound Quality Improvement
271
QA Data Flow
Feedback
Obtain Images
Ultrasonographer
QA Data Record
Fig. 16.1 An example QI owsheet showing the data ow in the QI process
Images and QA Data
are Reviewed
Images are Archived
These ve aspects of a QI program can be viewed as the ow diagram below (Fig.16.1)
We will now look at each of these topics in more detail.
Images Must BeObtained andStored forReview
Given the variety of ultrasound systems and methods of capturing and storing ultra­sound images it is not practical to list every option (Chaps. 17 and 18).
It is preferred that once the images are captured that they be transferred to an external archive system for review and storage. While QI can by directly completed on the ultrasound machine, ultimately the machines are not designed for long-term storage and date retrieval. Depending on the systems in place a program may prefer to use still images or video or both for review [1, 2].
The ideal image ow process allows for uploading of images and clips from the ultrasound machine directly to the EMR, to a QI system, to the ultrasound director, and back to the performing sonographer in a HIPAA compliant manner [1, 2].
272
Patient/ exam demographics:
Primary person obtaining/ interpreting images: _________________ Secondary person obtaining/ interpreting images: ________________ Additional person(s) obtaining/ interpreting images: _________________
The Sonologist Must Document Their Findings forEach Study Completed
After completion of an ultrasound study a sonographer should complete a US report form that corresponds with their documentation of the ndings that go into the chart. This sheet should also allow the sonographer to self-reect and com­ment on the adequacy of their ndings. This sheet should allow the sonographer to directly answer the yes/no questions regarding ndings from their examina­tion. On the US report forms, the sonographer should identify the indication for the exam as well as which views they were able to obtain. The sonographer should also comment on their interpretation of the images [1, 2, 27]. These forms can either be in paper format or computerized. Some workow solutions allow these forms to be lled out on the machine and then submitted with the exam, while others allow the user to complete the forms on the actual QI application. The ACEP Ultrasound Standard Reporting Guidelines [31] suggest the following data elements be included in all studies (Fig.16.2).
Below is a simple paper-based QI form (Fig.16.3).
Patient name: _______________________________
Patient gender: M F
DOB: ___ / ___ / ___
MR#: _____________________
Bar Code/Patient Identifier: ____________________
Hosptial Name: ____________________
Date and time of exam: ___ / ___ / ___
Exam type:
Clinical category:
Initial exam
Repeat exam
P.S. Hunt et al.
Diagnostic
Educational
Procedural
Resuscitative
Symptom based
Therapeutic
Unknown/other
Fig. 16.2 An example of a standard patient demographic form for a limited point-of-care ultra­sound examination