Assessment of Endoscope Reprocessing Using Peer-to-Peer Assessment Through a Clinical Community

The Joint Commission Journal on Quality and Patient Safety Infection Prevention and Control

Assessment of Endoscope Reprocessing Using Peer-to-Peer Assessment Through a Clinical Community Jonathan Teter, MS, CIC; Michael E. Zenilman, MD; Patricia Wachter, MA; for the Johns Hopkins Medicine Cleaning, Disinfection and Sterilization Clinical Community

C

leaning, disinfection, and sterilization (CDS) of medical devices is an important aspect of patient safety in the health care setting.1 The CDS processes employed in health care facilities help to prevent health care–associated infections (HAIs). HAIs are a significant cause of mortality and morbidity in the United States, affecting nearly 4.5% of hospitalized patients.2 In addition, a 2009 Centers for Disease Control and Prevention report estimated that direct, annual medical costs of HAIs range from $28.4 to $45 billion.3 Medical devices, particularly those used for invasive procedures, can present a significant risk for infection if they are not properly reprocessed. CDS encompasses a wide array of activities from the routine cleaning of rooms to the complex sterilization processes of sensitive invasive devices. The number of diverse products, devices, and technologies used in modern health care presents a challenging situation for CDS practices. Each device manufacturer may have different guidelines for proper cleaning and disinfection of the instrument, leading to numerous and complex procedures that need to be maintained, with little margin for error. Most invasive medical devices are used by a variety of provider types and in many multidisciplinary areas. Thus, the responsibility to ensure proper handling and cleaning of devices often falls on many different divisions or departments within a health care facility. Clinical communities, as described by Aveling et al.,4 share common goals for improvement and are empowered to work across disciplines and individual silos to achieve results. When discussing issues revolving around a broad practice, such as CDS, clinical communities can provide insight—because of the many disciplines involved—and engage clinicians in the processes surrounding care and use of medical devices. In February 2013, to streamline CDS practices and address risks for infection across the health system, the Johns Hopkins Health System (JHHS; Baltimore) formed a clinical community of 22 core members, which was led by two physician leaders and consisted of experts and stakeholders [including J.T., M.E.Z., P.W.], to assess CDS practices across facilities. In this article, we report on how peerJune 2016

Article-at-a-Glance Background: Cleaning, disinfection, and sterilization

(CDS) of medical devices are intended to help prevent health care–associated infections (HAIs), a significant cause of mortality and morbidity. In February 2013 the Johns Hopkins Health System (JHHS; Baltimore) formed a clinical community of experts and stakeholders—physicians, nurses, administrators, infection control practitioners, risk managers, and regulatory staff—to assess CDS practices across facilities. Methods: A survey administered to leadership indicated endoscopy areas of risk. An endoscopy tracer tool with eight major performance areas was then created from best practices identified in the literature, regulatory requirements, and national guidelines for endoscope reprocessing. Peer-to-peer (P2P) assessments using the tracer tool were performed at five Johns Hopkins Medicine gastrointestinal endoscopy sites (three hospital-based; two freestanding ambulatory surgery centers) selected on the basis of their large procedural volumes and their operational ability to participate in further areas of the project. Results: The P2P assessments revealed that 20 (42%) of the 48 possible criteria had a noted deficiency at one or more sites. Three of the eight major performance areas on the ­tracer tool had no deficiencies identified at any of the five sites. Deficiencies were mostly minor process improvements, and only one critical process required immediate alteration of practice. Because the assessments were nonpunitive, horizontal communication enabled feedback on process improvements, alternate methods to achieve outcomes, and solutions to common issues. Conclusions: A nonpunitive and collaborative peer methodology was successful in capturing and sharing best practices in endoscopy areas. Successful replication in other clinical areas can be an effective way to assess CDS processes and ­facilitate dialogue for improvements.

Volume 42 Number 6

Copyright 2016 The Joint Commission

265

The Joint Commission Journal on Quality and Patient Safety to-peer (P2P) assessments of high-volume endoscopy areas enabled the clinical community to collaborate with sites to improve endoscopy CDS practices as a system.

Methods Setting

Table 1. Membership (Degrees and Title) of the Cleaning, Disinfection and Sterilization Clinical Community: Participants Across the Johns Hopkins Health System Department of Participant

JHHS consists of 6 acute hospitals, 6 ambulatory surgery centers, and nearly 50 community/ambulatory sites. These components make up the “main campus” and “community division” (Table 1, right).

Infection Control

Establishing a Clinical Community In parallel with other clinical community efforts within the Johns Hopkins’ Armstrong Institute, the CDS Clinical Community was modeled on enterprisewide efforts in other disciplines, such as the ICU.5 Because numerous departments and disciplines have a stake in the CDS processes, the establishment of a clinical community enabled organizational leadership to create a truly representative cross-disciplinary collaborative to work on challenges related to CDS. The clinical community consisted of physician and nursing leaders, administrators, and representatives from infection control, regulatory, reprocessing, and central sterile processing areas (­Table 1).

Identifying Staff’s Perceived Areas of Risk In June 2013 through August 2013, through the SurveyMonkey platform (SurveyMonkey, Palo Alto, California), we surveyed the clinical community and hospital system staff for their knowledge and opinions. This CDS Clinical Community Risk Survey assessed staff’s perceived areas of risk (in both physical areas and processes areas). The survey consisted of 9 questions, and participants were asked to rank physical areas (for example, endoscopy, central sterile processing, operating room [OR]), as well as process areas (for example, education, competency assessment, material flow), on the basis of their experience, into highest- and lowest-risk categories. Two follow-up surveys were conducted. Consensus was ultimately achieved to focus on CDS practices in the endoscopy areas.

Conducting Peer-to-Peer Reviews We borrowed from our regulatory division a comprehensive, validated tool of best practices in the CDS reprocessing of flexible endoscopes and customized the 266

Hospital/ Facility

Location

RN, Infection Control Coordinator

JHBMC

Main Campus

MD, Director, Hospital Epidemiology

JHH

Main Campus

RN, Director, Infection Control

Sibley

Community Division

MD, Director, Infection Control

ACH

Community Division

RN, Infection Control Manager

HCGH

Community Division

MD, Anesthesia, Chief Medical Officer; Co-Chair, Clinical Community*

JHBMC

Main Campus

MD, Surgeon, Otolaryngology

JHH

Main Campus

MD, Plastic Surgery

JHH

Main Campus

MD, General Surgery, Chair

Sibley

Community Division

MD, Plastic Surgery

JHH

MD, Surgery, Regional Surgery Director; Co-Chair, Clinical Community*

Sibley, Suburban HCGH

Community Division

CRST ST, Sterile Processing Manager

Sibley

Community Division

RN, Manager, Central Sterile Processing

JHBMC

Main Campus

Director, Central Sterile Processing

JHH

Main Campus

Physician Leadership

Central Sterile Processing

Regulatory/Risk Management JD, Associate Risk Manager

JHH

Main Campus

RN, Director, Regulatory Compliance

JHCP

Community Division

JD, Risk Manager

Suburban

Community Division

RN, Senior Director, Accreditation/ Certification

JHH

Main Campus

RN, Joint Commission Specialist

JHH

Main Campus

Department Administrator

JHH

Main Campus

RN, Manager, Ambulatory Surgery Center

White Marsh

Community Division

RN, Manager, Ambulatory Surgery Center

Greenspring

Community Division

RN, Executive Vice President, Chief Operating Officer

Suburban

Community Division

RN, Regulatory Compliance Auditor Administrative Offices

JHBMC, Johns Hopkins Bayview Medical Center, Baltimore; JHH, Johns Hopkins Hospital, Baltimore; Sibley, Sibley Memorial Hospital, Washington, DC; ACH, All Children’s Hospital, St. Petersburg, Florida; HCGH, Howard County General Hospital, Columbia, Maryland; Suburban, Suburban Hospital, Bethesda, Maryland; JHCP, Johns Hopkins Community Physicians Group Practices, Baltimore; White Marsh/Greenspring (Maryland), location of freestanding ambulatory surgery centers. * The two physician leaders of the clinical community are labelled “Co-Chairs.”

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission

The Joint Commission Journal on Quality and Patient Safety Table 2. Cleaning, Disinfection and Sterilization (CDS) Clinical Community Risk Survey Results* Areas That Have the Highest Risk of Causing Harm

Response Percentage

Endoscopy/Bronchoscopy

42.9

Operating Room

71.4

Ambulatory Clinics

21.4

Central Sterile Processing

64.3

Inpatient Units

14.3

Procedural Units What Are the Top 3 Priorities?

42.9 Response Percentage

Education and training

80.0

Establishing and maintaining competency

46.7

Following manufacturer instructions for CDS

26.7

Traceability of instruments and devices

33.3

Challenges of physical space where processing occurs

20.0

Improper labeling and handling of sterile trays

 6.7

Standardization of processes throughout JHHS

66.7

Data collection and outcome measures

20.0

JHHS, Johns Hopkins Health System. * Based on results from responses from 15 (68%) of the core members of the CDS Clinical Community.

tool for the specifics of this project.6,7 The clinical community members and an external expert in endoscopy reviewed the tool to ensure completeness and inclusion of current requirements and best practices. We used this tool to conduct P2P reviews of hospital-based endoscopy areas and ambulatory surgery center sites that used flexible endoscopes. Participants completed the review either using a paper and pen or electronically (via the iAuditor app [SafetyCulture Corp., Sydney] for a tablet computer). We aggregated the results and discussed them with clinical community members.

Identification of Risk Initially, the CDS Clinical Community performed a risk survey, in which we invited all 22 core members to participate. The results of the survey, based on responses from 15 (68%) of the core members, are provided in detail in Appendix 1 (available in online article). Eighty percent (n = 12) of the respondents identified gaps in education and training as the highest risk area (Table 2, above). Two thirds (67%, n = 10) of the respondents identified the lack of standardization of CDS processes as another top risk area. The OR and central sterile processing were identified as the units/divisions of highest risk (71% and 64%, June 2016

respectively). Because of their complexity, endoscopy areas (43%) were also noted to be an area of risk that was conducive to an intervention pilot program. Subsequent discussion at monthly community conferences and a review of the literature yielded a consensus that endoscopy procedures are increasing in volume and present an increasing risk for postprocedure infection.8 Also, because endoscopy reprocessing is a procedure with established techniques, the clinical community believed that improvements to these CDS processes would be easier to address than those in the entire OR or central sterile processing areas. In July–August 2013 we sent the CDS Clinical Community Risk Survey, again, through the SurveyMonkey platform, to a total of 26 supervisory staff, physicians, and staff at five JHHS gastrointestinal endoscopy centers (three hospital-based; two freestanding ambulatory surgery centers), in Maryland, Virginia, and Washington, DC, so that we could better understand the CDS risks (Table 3, page 268). We selected these centers on the basis of their large procedural volumes and their operational ability to participate in further areas of the project. Sixteen of these 26 individuals at the five sites responded. The responses indicated that there was minimal physical risk and good written protocols but that there was variation in governance, inventory documentation, and how often reprocessing took place. Importantly, all the respondents believed that risk for postprocedure infections was due to how often correct procedures were followed in sterile processing, traceability of equipment, and tracking physical damage to endoscopes. We sent a comparable survey to practicing physicians in the centers, and, interestingly, the responses yielded very similar ­answers (not shown).

Endoscopy Tracer Tool In June–August 2013, our regulatory department adapted an endoscopy tracer tool from other sources,6,7and in the following month the clinical community refined it on the basis of best practices reported in the literature, regulatory requirements, and national guidelines.1,9–17 The tracer, provided in Appendix 2 (available in online article), was intended to create a catchall of CDS requirements and best practices for the ideal reprocessing of endoscopes. A small subgroup of the clinical community compiled the relevant guidelines for endoscope reprocessing and noted evidence-based best practices. All clinical community members then reviewed the tracer in terms of its thoroughness, content validity, usability, and functionality. The major performance ­areas were as follows: Volume 42 Number 6

Copyright 2016 The Joint Commission

267

The Joint Commission Journal on Quality and Patient Safety Table 3. Sample Responses in Assessment of Frontline Risk from Survey of Five Endoscopy Centers

Job Function

Location

Reports To

Inventory (If yes, who maintains?)

Physical Risk

Written Protocols/ Manufacturer’s Instructions

Document CDS Activities

Top 3 Concerns About Endoscope Safety

IP

Academic Medical Center

Infection Control Director

In Process

No

Yes/Yes

Yes

Storage Transport Traceability

Administration

ASC

Surgical Nursing Director

Partial Inventory/ Nurse Manager

No

No Response

No Response

Only scope is for endobrow procedure

Manager, Central Sterile Processing

Community Hospital

Perioperative Director

Yes/Central Sterile Processing

No

In Process/Yes

Yes

Following manufacturer’s instructions All steps each time

Manager, Central Sterile Processing

ASC

Surgical Services Director

In Process

No

Yes/Yes

Yes

Education Precleaning after use Safe handling of scope to avoid damage

Nurse

OP Otolaryngology

Director OP Nursing

In Process

No

Yes/Yes

Yes

Tracking of scope Sterilization procedure compliance

CDS, cleaning, disinfection and sterilization; IP, infection preventionist; ASC, ambulatory surgery center; OP, outpatient.

General Documentation Requirements Endoscope Reprocessing Room Requirements ■■ Pre-Cleaning at the Point of Use ■■ Cleaning (including leak testing) ■■ High-Level Disinfection ■■ Rinsing ■■ Drying ■■ Storage Each major performance area was broken down into criteria that included the best practices and regulatory requirements. Overall, there were 48 criteria in the tracer tool. Several criteria had multistep processes; however, for scoring purposes, if any of the multisteps were deemed to be missing, the larger item was considered incomplete. Because of the large number of different endoscopes in use, the tracer did not specifically address any one particular manufacturer’s instructions for use. Each product manufacturer may vary its instructions for cleaning, so the evaluators would ask each site for the instructions should there be any doubt or concern that the site was not following procedures. ■■ ■■

Peer-to-Peer Assessments for Tracer Teams In October 2013 we formed six teams in which nonclinicians (risk, regulatory, administrative, and infection control practitioners) were paired with clinicians (physicians, nurses) to provide both groups’ perspectives for each tracer team. We performed P2P reviews with the endoscopy tracer tool at the five 268

June 2016

gastrointestinal endoscopy sites. Each review followed the reprocessing procedure from start to finish. Any deficiencies noted in the process were discussed with the facility staff at the time of the survey, including proposed solutions or corrections needed.

Results The P2P assessments performed at the five sites revealed that 20 (42%) of the 48 possible criteria had a noted deficiency at one or more sites. Of the eight major performance areas on the tracer tool, three areas—general documentation, high-level disinfection, and rinsing—had no deficiencies identified at any of the five sites. Proper storage of endoscopes was revealed to have the most defects, with at least one site deficient in each criterion in this performance area Deficiencies were mostly noncritical process improvements, with only one critical item that required immediate alteration of practice, which concerned transportation of scopes. During the assessments, horizontal communication developed between endoscopy center leadership and the clinical community surveyors to improve processes, listed as follows: ■■ Separate sinks for washing (hand washing, clean area procedures) were recommended for areas that had only one sink. The group subsequently added to the tracer a step regarding routine cleaning of the disinfecting sink after rinsing is complete to ensure that it was performed before the endoscope reprocessing was finished. Volume 42 Number 6

Copyright 2016 The Joint Commission

The Joint Commission Journal on Quality and Patient Safety ■■ We also implemented procedures to improve how and when air exchanges were monitored. In several facilities that share multiple clinics, a facilities staff member would perform the monitoring for the building. Access to the records and/or ensuring completion of the monitoring was difficult, particularly in buildings not owned and managed by JHH. The group recommended to all sites to keep copies of the records or setting regular meetings with facility staff to ensure that monitoring was complete, and to discuss any results from the air exchange tests. ■■ It was also noted that proper transportation and identification of dirty endoscopes was needed. Endoscopes were to be transported from the procedure room to the reprocessing room in clearly marked containers so that any person could identify a particular unit as “dirty.” ■■ The storage of endoscopes between procedures, one of the most common areas for improvement identified across multiple areas, was addressed. Because several procedure areas use different types of endoscopes, with the resulting variation in length, shape, and other characteristics, it was challenging to hang the instruments properly. This was particularly seen in centers with limited physical space for storage. Several cabinets were replaced or modified to ensure that proper hanging and ventilation of the endoscope storage cabinet was maintained. In high-volume procedure areas, tagging of endoscopes with time and initials of the technician was not routinely completed because the endoscopes were used almost daily. This, too, was assessed and an updated identification of processed endoscopes was implemented.

Discussion Using the P2P assessments of high-volume endoscopy areas within JHM enabled the CDS Clinical Community to collaborate with sites to improve endoscopy CDS practices on a systemwide basis. The clinical community promoted the development of relationships and formation of trust between multiple organizational levels at multiple sites, which included inpatient and outpatient settings in Maryland, Virginia, and Washington, DC. Because the assessments were nonpunitive, open discussions occurred at the local level between reviewers and process owners. Horizontal communication across similar entities provided feedback on process improvements, alternate methods to achieve outcomes, and solutions for systemwide approaches to common challenges. Each team was able to discuss in real time any challenges or issues identified during the P2P assessment. The debriefing meeting was typically held right after the P2P assessment. For improvements involving modification of physical space, the ability to have discussions within the clinical community group June 2016

lent credence to the suggestions made and provided multifacility support for changes that would affect the supply chain. Our P2P assessment was limited because of the schedules and workload of the clinical community members, which resulted in the initial focus on high-volume and/or hospital-based procedure areas. Selection of the endoscopy centers for P2P also was limited by volume, staffing, and scheduling of the centers, so that all endoscopy centers in the health system were not able to be reviewed in the initial P2P. Future replication of this process is expected to include a wider variety of areas involved in processing endoscopes, including ORs, ICUs, outpatient areas, and physician practices. Discussions are under way with administration to support this by changing job descriptions of supervisors to include P2P. Another limitation was the inability to identify differences in performance between freestanding ambulatory surgery centers and hospital-based procedure areas because of the small number of surveys administered and P2P assessments performed. Finally, in our initial survey we did not use any predefined test to assess knowledge of best practices or regulatory standards. Importantly, the trust and open communication that developed during a period of 18 months in the clinical community enabled JHHS to rapidly respond to subsequent carbapenem-resistant Enterobacteriaceae (CRE) outbreaks and modify guidelines for specialty endoscopes.18,19 As a result, in a period of two weeks, JHHS uniformly changed the processing of these specialty endoscopes to include screening for resistant contamination. Periodic assessment and communication between assessed sites has been planned through clinical community activities to perform ongoing assessment and to share best practices. As of this writing, a single reprocessing standard has not been adopted, but the clinical community has been drafting sets of practice and competency standards. Ongoing quality improvement and assessment continues through the clinical community, which remains active and continues to meet. As standard policies are adopted, periodic review and P2P will help to maintain any changes implemented within the process. On the basis of our experience, we plan to employ the power of the clinical community to further enhance CDS processes across JHHS. This will include the development of JHHS–wide CDS policies and procedures and the creation of mechanisms for oversight of competency, certification, and recertification of frontline staff who perform this critical function. Efforts to create standard competency and educational materials covering the basics of reprocessing technique will be addressed as the community moves forward, including review of the Joint Commission Standards BoosterPak™.20 Prior to our assessment, no single standard or recommended training was in place at many of the Volume 42 Number 6

Copyright 2016 The Joint Commission

269

The Joint Commission Journal on Quality and Patient Safety facilities, beyond training required for certifications. The clinical community believed that an easily accessed series of training modules would be useful in ensuring that those involved in the reprocessing procedure had a basic knowledge and skill set, regardless of whether any specific external certification was required specific to reprocessing. P2P assessments will be expanded to include other areas where CDS processes currently occur. A second phase of P2P will be prepared for reprocessing of endoscopes in areas other than the endoscopy suite, such as the OR and ICUs. In addition, this expansion will include ambulatory and outpatient physician practice settings, in which reprocessing of endoscope equipment may not have the same level of infrastructure and oversight as hospital-based procedure areas. We anticipate that this process will result in further refinement of assessment tools to capture specific details for each practice setting, allowing for thorough discussion between peer groups.

Conclusion A nonpunitive and collaborative P2P assessment methodology that can be used to objectively identify patient safety risks and prevent harm enabled the capture of practice deficiencies and the sharing of CDS best practices in endoscopy areas. This process’s effectiveness in identifying risk in high-volume endoscopy suites suggests that the methodology can be successfully implemented at other reprocessing sites. J The authors gratefully acknowledge the Cleaning, Disinfection and Sterilization Clinical Community members (Renee Blanding, Karen Carlson, Lisa de Grouchy, Sarah Disney, Adrienne Dixon, ­Tresa Fitch-Childs, Susan Franklin, JoEllen Harris, Beverly Holloway, Kerri Huber, Lisa ­Maragakis, Marie Marshall, Helen McGrain, Barbara O’Connor, Trish Perl, Carolyn Perry, Kathy Moore, Samantha Oates, ­ Stephanie Reed, Gedge Rosson, Lois Scarborough, Kristine Smith) and Jonathan Teter’s fellow survey team members (Lisa de Grouchy, Sarah Disney, Adrienne Dixon, Tresa Fitch-Childs, JoEllen ­Harris, Beverly Holloway, Kerri Huber, Marie Marshall, Carolyn Perry, Stephanie Reed, Kristine Smith). The authors extend a special acknowledgement to Susan Franklin, Director, Regulatory Affairs Department, Johns Hopkins Health System, for initial development of the operational tracer tool. They also acknowledge the external expert in endoscopy (Nancy Chobin, PhD, Lebanon, New Jersey), for her expert review of the tracer tool.

Jonathan Teter, MS, CIC, formerly Program Administrator, Epidemiology and Infection Prevention, Johns Hopkins Health System, Baltimore, is Research Data Manager, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore. Michael E. Zenilman, MD, is Professor of Surgery, Johns Hopkins University School of Medicine. Patricia Wachter, MA, is Senior Project Administrator, Clinical Communities, Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore. Please address correspondence to Michael E. Zenilman, [email protected].

270

June 2016

Online Only Content http://www.ingentaconnect.com/content/jcaho/jcjqs See the online version of this article for Appendix 1. Cleaning, Disinfection and Sterilization (CDS) Clinical Community Risk Survey with Results and Free-Form Comments Appendix 2. Johns Hopkins Health System Reprocessing Tracer

References

1. Rutala W, Weber DJ; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Atlanta: Centers for Disease Control and Prevention, 2008. 2. Klevens RM, et al. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122:160–166. 3. Scott RD II. The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. Atlanta: Centers for Disease Control and Prevention, Division of Healthcare Quality Promotion, 2009. 4. Aveling EL, et al. Quality improvement through clinical communities: Eight lessons for practice. J Health Organ Manag. 2012;26:158–174. 5. Gould LJ, et al. Clinical communities at Johns Hopkins Medicine: An emerging approach to quality improvement. Jt Comm J Qual Pat Saf. 2015;41:387–395. 6. Oregon Patient Safety Commission. Oregon Patient Safety Commission Endoscope Reprocessing Competency Checklist. Accessed May 2, 2016. http:// oregonpatientsafety.org/docs/tools/3.05_Endoscope_Reprocessing_Competency _Checklist.doc. 7. Chobin N. Annual Competency for Endoscope Reprocessing Form. In The Basics of Flexible Endoscope Reprocessing. Lebanon, NJ: Sterile Processing University, 2012. 8. Dirlam Langlay AM, et al. Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. Am J Infec Control. 2013;41:1188–1194. 9. ECRI Institute. Reprocessing of Flexible Endoscopes: Executive Summary Supplement A. Guidance document. Plymouth Meeting, PA: ECRI Institute, 2012. 10. ECRI Institute. Clear channels: Ensuring effective endoscope reprocessing. Health Devices. 2010;39:350–359. 11. Clarification: Requirements for an endoscopy equipment processing room. Jt Comm Perspect. 2012;32(3):13–14 12. Petersen BT, et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2011. Infect Control Hosp Epidemiol. 2011;32:527–537. 13. Society of Gastroenterology Nurses and Associates (SGNA). Standards of ­Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. Chicago: SGNA, 2012. 14. Association of periOperative Registered Nurses (AORN). Recommended practices for cleaning and processing flexible endoscopes and endoscope accessories. In AORN Perioperative Standards and Recommended Practices. Denver: AORN, Inc; 2013: 473–484. 15. Association for Professionals in Infection Control and Epidemiology. Cleaning, Disinfection, and Sterilization. Rutala WA, Weber DJ. Feb 25, 2016. (Updated: Apr 1, 2016.). APIC Text Online. Accessed May 2, 2016. http://text.apic.org/. 16. Association for Professionals in Infection Control and Epidemiology. Endoscopy. May D. Oct 3, 2014. APIC Text Online. Accessed May 2, 2016. http://text .apic.org/. 17. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2015: Flexible and Semi-rigid Endoscope Processing in Health Care Facilities. Apr. 2015. Accessed May 2, 2016. http://my.aami.org/aamiresources/preview files/ST91_1504_preview.pdf. 18. Epstein L, et al. New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA. 2014 Oct 8;312:1447–1455. 19. Centers for Disease Control and Prevention. Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes After Reprocessing. Mar 11, 2015. (Updated: Apr 3, 2015.) Accessed May 2, 2016. http:// www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html. 20. The Joint Commission. Standards BoosterPaks™: A Quality Improvement Tool. High-Level Disinfection (HLD) and Sterilization BoosterPak. Dec 7, 2015. Accessed May 2, 2016. http://www.jointcommission.org/standards_booster_paks/.

Volume 42 Number 6

Copyright 2016 The Joint Commission

The Joint Commission Journal on Quality and Patient Safety Online Only Content



Appendix 1. Cleaning, Disinfection and Sterilization (CDS) Clinical Community Risk Survey with Results and Free-Form Comments* What is your content expertise? Expertise

Response Percentage

Infection Prevention

33.3

Sterile Processing

13.3

Risk

6.7

Regulatory

20.0

Anesthesia

0.0

Surgery

33.3

Medicine

6.7

Endoscopy/Bronchoscopy

6.7

What is the greatest barrier to improving the CDS process in your area? • Large, slow and cumbersome bureaucracy. • Properly trained staff. • Facility space capabilities. • Communication and the magnitude of instruments that need to be processed. • Everyone knowing their role. • No standardized processes. What three areas have the highest risk of causing harm to patients? Areas

Response Percentage

Environmental Disinfection

13.3

Endoscopy/Bronchoscopy

Administration

13.3

Operating Room

71.4

Management

13.3

Ambulatory Clinics

21.4

Sterile Processing

64.3

Inpatient Units

14.3

Procedural Units

42.9

What is your role? Expertise

Response Percentage

Physician

20.0

Nurse

26.7

Nurse Practitioner Infection Prevention Quality

0 26.7 0

Administrator

13.3

Management

13.3

Director/Employee CSP

6.7

Director/Employee EVS

0

How do you define risk (activity or inactivity that may cause harm to patients) for cleaning? • Failure to follow manufacturer’s instructions. • Staff’s limited knowledge base—not understanding the importance/ rational for each step of process, starting with the basics. Lack of specific cleaning guidelines in the clinic areas, lack of buy-in of the staff, often viewed as just another chore. • Missing standardized practice. How do you define risk (activity or inactivity that may cause harm to patients) for disinfection? • Improperly cleaned scopes. • Insufficient knowledge of the need for engineering devices and why they are important. • Infection or contamination with infectious organisms or blood borne pathogens. • Instruments not fully disinfected or damaged or missing because of the disinfecting process. • Knowledge deficit. How do you define risk (activity or inactivity that may cause harm to patients) for sterilization? • Not sterile if not cleaned properly. • Instruments not fully sterilized or damaged or missing because of the sterilization process.

42.9

What are two things that are currently working well for you related to CDS process? • Terminal cleaning of the rooms. • High-level disinfection and endoscopy suite. • Available resources—internet, manuals, and professionals contacts. • Understanding of basic CDS workflow. • Training process for staff with regard to how instruments should be sterilized following procedures. • Our CDS manager is very knowledgeable about the standards. • Consistency in staffing, certified personnel, open channels of communication. • Standardized process for containing dirty equipment. Once we identify the areas of highest risk, what are the top three priorities where the clinical community should begin this important work? Priorities

Response Percentage

Education and training

80.0

Establishing and maintaining competency

46.7

Following manufacturer instructions for CDS

26.7

Traceability of instruments and devices

33.3

Challenges of physical space where processing occurs

20.0

Improper labeling and handling of sterile trays

6.7

Standardization of processes throughout JHHS

66.7

Data collection and outcome measures

20.0

CSP, Central Sterile Processing; EVS, Environmental Services; JHHS, Johns Hopkins Health System. * Based on results from responses from 15 (68%) of the core members of the CDS Clinical Community.

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission

AP1

The Joint Commission Journal on Quality and Patient Safety Online Only Content



Appendix 2. Johns Hopkins Health System (JHHS) Endoscope Reprocessing Tracer*

JHHS ENDOSCOPE REPROCESSING TRACER TOOL Surveyor Name(s): ____________________________

Date:

1

__________________________

Staff Name (Observed and/or Interviewed): _________________________________________________ Affiliate:______________________

Department: _________________

Performance Criteria

Yes

No

N/A

Comments

I. GENERAL DOCUMENTATION REQUIREMENTS 1. 2.

3. 4. 5.

Manufacturers’ Instructions for Use (IFUs) are accessible and referred to by staff (for endoscopes, endoscope accessories, and re-processing equipment). Policies related to endoscope reprocessing methods are accessible to staff. Safety Data Sheets (SDS) for each chemical utilized in endoscope reprocessing are accessible to staff. Staff have received initial training with verification of competencies for all scopes, accessories and associated equipment (e.g. AER) and have updated competencies (annually). Logs (electronic or paper) are maintained with full traceability of the scope (e.g. serial #) to the patient, including who processed the scope.

II. ENDOSCOPE REPROCESSING ROOM REQUIREMENT with

1. Endoscope reprocessing room is free of any dividing walls (e.g. curtain, temporary dividers are not allowable). 2. Decontamination room air pressure is negative to surrounding spaces. 3. Room air exhausts directly outside (air cannot be reused elsewhere in the building), 4. Minimum # of Air Changes Per Hour: Air is changed a minimum of 10 times per hour and 2 of the 10 air changes are fresh, outside air. 5. Water quality is tested annually. 6. Spill neutralizer is readily available as needed per high level disinfectant manufacturers. 7. Endoscope reprocessing room contains the following: • • •

Look for physical evidence (“show me”). Look for physical evidence. Look for physical evidence. Look for physical evidence.

Look for physical evidence.

Summon Facilities for questions or problems #1 - #5 in this section. Procedural barriers are in place to prevent cross contamination. Door to room must be kept closed to maintain negative pressure. There are no requirements for relative humidity or temperature. Look for physical evidence. Look for physical evidence.

Sinks to manually clean flexible endoscopes Separate hand-washing sink

Eyewash station (clean sink, may be handwashing sink) 8. Chemical Handling: High-level Disinfectant: a. When indicated, activates and mixes high-level disinfectant (as needed following manufacturers recommendations) at the beginning of the day or before the endoscopic procedure. Transfers high-level disinfectant into processing bin/AER.

Ask the question: How do you mix and dispose of chemicals?

Final 10-30-13

* This tool is provided for other health care organizations’ use or adaptation, but users are requested to inform Dr. Zenilman of its intended use.

(continued on page AP3)

AP2

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission

The Joint Commission Journal on Quality and Patient Safety Online Only Content



Appendix 2. Johns Hopkins Health System (JHHS) Endoscope Reprocessing Tracer (continued) 2

Performance Criteria

Yes

No

N/A

b. Disposes of chemicals appropriately per dept processes and the disinfectant manufacturer’s IFU. 9. Chemical Documentation a. Maintains high-level disinfectant logbook with:

• •

Dates of activation and expiration

•

Each use high-level disinfectant strip results checked (pass/fail), with appropriate followup actions if test strip fails

• • • • b.

Comments

Look at the logbook (paper or electronic) to verify.

Type and percentage of high-level disinfectant solution Validates correct QC strip is being used.

Documents corresponding date with strip in log book. Labels QC strip bottle with expiration date.

Performs QC, if required by manufacturer, on test strips per guidelines when bottle is first opened and documents results. Soaking bin is labeled with the following information filled in/checked off:

• •

Date of activation and expiration

Type and percentage of high-level disinfectant solution

III. PRE-CLEANING AT THE POINT OF USE 1. 2. 3.

Wears personal protective equipment (PPE) including impervious gowns, gloves as recommended by the high level disinfectant manufacturer, chemical goggles, or face shield. Immediately following invasive procedure, and while still in procedure room: a. Wipes exterior of scope with enzymatic solution.

Process not observed, verbal confirmation

b. Flushes suction channels with enzymatic and air. Transports used scope from procedure room to decontam room in scope bag or covered bin marked as Biohazard.

1.

Wears personal protective equipment (PPE) including impervious gowns, gloves as recommended by the high level disinfectant manufacturer, chemical goggles or face shield, and fluid resistant mask. 2. Visually inspects the endoscope, universal cord, and bending section (as applicable) for holes, tears, or other gross damage. 3. Performs leak testing according to manufacturer’s instructions. 4. If the endoscope is leaking, calls the manufacturer for repair. Follows manufacturer’s recommended procedures for preparation of the endoscope before sending out for repair. Final 10-30-13

Ask what you would do if scope is leaking?

(continued on page AP4)

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission

AP3

The Joint Commission Journal on Quality and Patient Safety Online Only Content



Appendix 2. Johns Hopkins Health System (JHHS) Endoscope Reprocessing Tracer (continued) 3

Performance Criteria

Yes

No

N/A

Comments

5. Manual Cleaning with an Enzymatic Solution: Detaches all removable parts (as applicable), soaks them and brushes them to remove debris. Rinses parts with water. 6. Immerses endoscope completely in enzymatic solution and thoroughly cleans the exterior of the endoscope. 7. Cleans inside the suction valve, air water valve, biopsy port openings and all other channel openings (as applicable) with a brush or lint free applicator. a. Chooses correctly sized channel brush. b. Brushes in the direction of the distal tip from the biopsy port. c. Brushes the channel between the suction valves. d. the

e. f.

Brushes the channels in the direction of the light guide connector. Uses short choppy strokes with the brush. Cleans the bristles of the brush each time it exits

endoscope before retracting. Repeats brushing until no debris is visible on the brush. h. With an ERCP endoscope, deflects and cleans around the elevator. i. Carefully, uses a soft brush to break up any blockage present at the tip of the air/water channel. 8. Attaches cleaning adapters to the endoscope and covers the biopsy port. 9. Immerses the endoscope, suctions in and soaks the endoscope in enzymatic solution for the manufacturer’s recommended amount of time. 10. Rinses the endoscope and all removable parts (as applicable) under running water to remove residual enzymatic solution. 11. Flushes all channels with water. 12. Purges all channels with air. 13. Removes excess water from the exterior of the endoscope to prevent dilution of high-level disinfectants used in the next step (using lint free cloth). 14. Fresh enzymatic solution is used for each scope cleaned. 15. Cleaning implements (brushes) are disposed of or cleaned and high level disinfected (including the sink) after each scope is cleaned. g.

Ask how long scope soaks in enzymatic solution.

Note: The endoscope may need to be completely dried at this point if being processed by an AER or other system.

V. HIGH-LEVEL DISINFECTION 1.

Please note if gluteraldehyde is used.

For Manual Disinfecting: a. Immerses the endoscope in disinfectant.

b. Using the cleaning adapters fills all channels Final 10-30-13

(continued on page AP5)

AP4

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission

The Joint Commission Journal on Quality and Patient Safety Online Only Content



Appendix 2. Johns Hopkins Health System (JHHS) Endoscope Reprocessing Tracer (continued) 3

Performance Criteria

Yes

No

N/A

Comments

5. Manual Cleaning with an Enzymatic Solution: Detaches all removable parts (as applicable), soaks them and brushes them to remove debris. Rinses parts with water. 6. Immerses endoscope completely in enzymatic solution and thoroughly cleans the exterior of the endoscope. 7. Cleans inside the suction valve, air water valve, biopsy port openings and all other channel openings (as applicable) with a brush or lint free applicator. a. Chooses correctly sized channel brush. b. Brushes in the direction of the distal tip from the biopsy port. c. Brushes the channel between the suction valves. d. the

e. f.

Brushes the channels in the direction of the light guide connector. Uses short choppy strokes with the brush. Cleans the bristles of the brush each time it exits

endoscope before retracting. Repeats brushing until no debris is visible on the brush. h. With an ERCP endoscope, deflects and cleans around the elevator. i. Carefully, uses a soft brush to break up any blockage present at the tip of the air/water channel. 8. Attaches cleaning adapters to the endoscope and covers the biopsy port. 9. Immerses the endoscope, suctions in and soaks the endoscope in enzymatic solution for the manufacturer’s recommended amount of time. 10. Rinses the endoscope and all removable parts (as applicable) under running water to remove residual enzymatic solution. 11. Flushes all channels with water. 12. Purges all channels with air. 13. Removes excess water from the exterior of the endoscope to prevent dilution of high-level disinfectants used in the next step (using lint free cloth). 14. Fresh enzymatic solution is used for each scope cleaned. 15. Cleaning implements (brushes) are disposed of or cleaned and high level disinfected (including the sink) after each scope is cleaned. g.

Ask how long scope soaks in enzymatic solution.

Note: The endoscope may need to be completely dried at this point if being processed by an AER or other system.

V. HIGH-LEVEL DISINFECTION 1.

Please note if gluteraldehyde is used.

For Manual Disinfecting: a. Immerses the endoscope in disinfectant.

b. Using the cleaning adapters fills all channels Final 10-30-13

(continued on page AP6)

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission

AP5

The Joint Commission Journal on Quality and Patient Safety Online Only Content



Appendix 2. Johns Hopkins Health System (JHHS) Endoscope Reprocessing Tracer (continued) 5

Performance Criteria

Yes

No

N/A

Comments

before leaving reprocessing room.

VIII. STORAGE 1.

Hangs flexible endoscopes vertically in a well-ventilated area.

2. Stores endoscope in a protected manner, but does not store in case. a. Removes water-resistant cap if used.

3. 4. 5.

b. Attaches venting cap for storage, if needed. Scopes are tagged with date of processing and tech’s initials.

Cabinet must be closed, ventilated, composed of all wipeable surfaces. Scopes may not touch each other, sides, or bottom.

How long are scopes stored between patients before being reprocessed? Should not be more than 30 days.

Verbalizes process for routine soaking bin cleaning and storage when not in use. Stores removable parts separately. (i.e., air/water & suction buttons, biopsy caps, water-resistant caps).

IX. MISCELLANEOUS 1. 2. 3. 4. 5.

Water bottles and tubing are sterilized daily. Quality Control measures are applied and followed through entire reprocessing cycle. Ask: Where are other scopes stored, if any?

What is the process for recalls? Ask what process is in place, if any, for differentiating a clean scope from a dirty one, anywhere along the high-level disinfection process, if the process is interrupted for some reason and the scope is laid down.

Final 10-30-13

AP6

June 2016

Volume 42 Number 6

Copyright 2016 The Joint Commission