Outbreaks of viral and bacterial infections associated with lapses in infection control standards in outpatient settings-including several outbreaks of hepatitis C virus infection-have received significant media attention.1 In a 2007 outbreak at a Nevada endoscopy center, more than 60,000 patients were notified that they might have been exposed to hepatitis C because of syringes and medication vials that were reused and that they should be tested for the disease.2 Two of those patients have since died from disease contracted during the outbreak; the physician and anesthetist working at the center were convicted on multiple counts and are currently incarcerated. Lapses in infection control identified during such events provide a basis for development and implementation of improvement strategies built on evidence-based best practices and national goals.
In 2009, the Centers for Medicare and Medicaid Services (CMS) introduced a tool for use by state survey agencies in auditing infection control and prevention practices at ambulatory surgery centers (ASCs), called the ASC Infection Control Surveyor Worksheet (ICSW). Publication of worksheet data from a pilot study of three states revealed deficiencies in practices related to hand hygiene, the handling of blood glucose monitoring equipment, injection practices, disinfection, sterilization, and environmental cleaning.3
Specific examples of serious lapses during investigations included
* the failure to perform hand hygiene or wear gloves when appropriate.
* the use of needles, syringes, prefilled syringes, fluid-infusion sets, and single-dose vials for more than one patient.
* injections being prepared in unclean workspaces.
* the failure to clean instruments prior to sterilization.
* the incorrect use of high-level disinfectants and chemical and biologic indicators.
* sterile equipment not being stored in a clean area.
* "high-touch" equipment in operating rooms and patient care areas not being appropriately cleaned.
* blood glucose monitors not being cleaned between patients and insulin pens being used for multiple patients.
In 2013, the U.S. Department of Health and Human Services (DHHS) released a multiyear action plan with the goal of eliminating health care-associated infections at ASCs.4 Steps that must be taken to accomplish this include requiring ASC staff to be 100% in compliance with all practices laid out in the ICSW that are related to surveillance, hand hygiene, the handling of blood glucose monitoring and other point-of-care equipment, safe injection practices, disinfection, sterilization, and environmental cleaning.
In 2011, the Pennsylvania Patient Safety Authority conducted a survey of 134 administrators, directors of nursing, and clinicians at ASCs to determine their perceptions of infection prevention and control at their facility. The responses revealed opportunities for improvement across the state in infection control training and education, surveillance, injection practices, sterilization, and environmental cleaning.
Event Reports
ASCs in Pennsylvania are classified as ambulatory surgical facilities, along with other facilities such as pain clinics and endoscopy centers. Pennsylvania's Medical Care Availability and Reduction of Error Act of 2002 (known as Mcare) requires Pennsylvania ASCs to report serious events and incidents to the Pennsylvania Patient Safety Reporting System (PA-PSRS). Mcare defines an incident as an event, occurrence, or situation involving the clinical care of a patient in a medical facility that could have injured the patient but didn't cause an unanticipated injury or require the delivery of additional health care services to the patient. Mcare defines a serious event as an event, occurrence, or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.
The event reports from Pennsylvania ASCs from March 2004 through July 2012 are summarized as follows:
* Surgical-site infections accounted for 84% of the 733 events that were related to infection control.
* The remaining 16% were related to problems with the sterilization of equipment, devices, or surgical supplies or with breaks in sterile technique during procedures, treatments, or tests.
* Disinfection or sterilization events accounted for the majority of the reports not related to surgical-site infections, followed by contamination of the sterile field, expired or recalled products, and breaks in sterile technique. More than 50% of the sterilization-related errors were discovered after the instruments reached the patient (see Figure 1).
* Knee- and shoulder-joint infections were the most common of the top five surgical-site infections reported, followed by infections of ankle or foot, the eye, the abdomen, and the hand or wrist.
These five types of surgical-site infection were most often associated with the following procedures:
* 51% of eye infections were associated with cataract surgery
* 48% of the knee- and shoulder-joint infections were associated with arthroscopy or rotator cuff repair
* 42% of the abdominal infections were associated with hernia repair
* 34% of the foot infections were associated with bunionectomy
* 31% of the hand and wrist infections were associated with carpal tunnel surgery
In addition, 36% of the patients with surgical-site infections required secondary medical procedures, such as amputation, vitrectomy, incision and drainage, or removal of an implant or hardware; 67% of the patients with surgical-site infections were treated with antibiotics, and 24% required hospitalization to treat the infection.
Examples from the Event Reports
The following are examples of events related to surgical-site infections, disinfection, and sterilization reported to PA-PSRS:
* A patient developed an infection six days [after] cataract removal, resulting in complete loss of vision.
* After knee arthroscopic surgery, the patient developed pain, redness, and purulent drainage from the incision requiring hospital admission for surgery [and] iv antibiotics.
* Ten days [after] left-foot bunionectomy, the patient tested positive for osteomyelitis with a resistant organism, requiring great-toe amputation.
* The flush step in the sterilization process of cleaning colonoscopes was omitted[horizontal ellipsis]. All staff [underwent reeducation on] the endoscopy cleaning process.
* The nurse noticed 20 minutes into the [procedure] that the indicator in the arthroscopy instruments had not changed color to indicate that sterilization had occurred.
* At the end of the day, the technician collecting the autoclave sheets discovered that a set of instruments [had been] put in the autoclave to be sterilized but for some reason the autoclave was not run. The instruments [had been] removed from the autoclave unsterile and used [in the care of] a patient.
Strategies to Enhance Compliance
The PA-PSRS reports, as well as the CMS surveys and Centers for Disease Control and Prevention (CDC) investigations, reveal a need for the development of targeted approaches to enhancing infection control practices in ASCs. The following five basic strategies distill best practice concepts from several nationally accepted guidelines for integration into clinical practice in ASCs.
Follow sterilization and disinfection standards. Strict compliance and demonstrated competency among all staff involved in the handling, cleaning, disinfection, sterilization, transport, and storage of surgical equipment are crucial.5-8
* Document the competency of staff.
* Ensure a clear understanding of and compliance with the steps in the endoscope cleaning process and with use of immediate-use (flash) sterilization, which should be used only in urgent and unpredicted situations.
* Institute a structured, written review process for specific equipment-cleaning, disinfection, and sterilization protocols. This includes the cleaning of point-of-care equipment such as blood glucose monitors.
* Monitor chemical, biologic, and mechanical sterilization indicators.
* Develop a process for recognizing and taking remedial action in the case of sterilization failures.
* Follow manufacturers' instructions for high-level disinfection and reprocessing of surgical equipment, as well as sterilizer use.
Integrate safe injection and point-of-care medical device practices into clinical practice.
Integration of safe injection standards into clinical practice includes requiring compliance and then monitoring clinician practices to prevent contamination of syringes, needles, and medication vials.9-12
* Use a new syringe and needle for every injection, as well as every time iv tubing, flush solution, and vials are accessed.
* Use single-dose vials for one patient, one procedure, and then discard them because they don't contain an antibacterial preservative.
* Multidose vials are considered contaminated if used to treat a patient in the immediate patient care area and are therefore not to be used to treat another patient. When multidose vials must be used, keep them in a central medication area and never take them to the bedside or the stretcher side.
* Opened multidose vials must be dated and have an expiration date of within 28 days after opening or the number of days specified by the manufacturer, whichever comes first.
* Antibacterial preservatives don't provide protection against blood-borne viral organisms.
* Make sure that there is accountability for all clinicians and anesthesia personnel regarding compliance with basic aseptic techniques, such as hand hygiene and the cleaning of vial septums each time they're accessed.
Implement surveillance techniques. Standardization of the surveillance process enhances an ASC's ability to recognize, track, analyze, and prevent surgical-site infections associated with care at the center.13
* Investigate, rule out, or classify infections according to guidelines from the CDC's National Healthcare Safety Network (NHSN), which provides standardized surveillance definitions so that all ASCs consider the same things to be infections and comparisons between rates are accurate. It's important that staff performing surveillance use these nationally standardized definitions, which will prevent facilities with high infection rates from making up their own definitions in order to exclude, for example, high-risk patients.
* Use a hybrid of surveillance sources, including postdischarge surveys, phone calls, or questionnaires to surgeons and patients.
* Provide physicians and surgeons with handouts describing NHSN surgical-site infection criteria.
* Establish communication with nearby hospitals to receive reports if former patients are admitted with an infection related to a procedure performed at the ASC and track rates of secondary procedures.
Ensure strict environmental control practices. Effective environmental cleaning systems require communication and accountability, as well as proper, regular cleaning and monitoring in operating room suites and patient care areas.5
* Monitor rapid turnover schedules for infection control challenges such as beginning setup for a new case prior to completion of cleaning from a prior case.
* Monitor cleaning compliance-prior to the day's first case, between cases, and at end of day (terminal cleaning).
* The Association of periOperative Registered Nurses provides detailed guidance on containment, cleaning, disinfecting, and surveillance during construction and in rooms under isolation precautions.
Require standardized education and training.14
* A qualified, licensed health care professional should direct the ASC's infection control program.
* All staff, including contractors, must complete job-specific infection control training and competency. Document all evaluations and educational sessions.
* Require staff to perform all components of a procedure in practice or in simulation with a supervisor present.
Assessing Infection Control Practice
A structured practice analysis can help an ASC integrate infection control best practices into its own clinical practice and determine whether all aspects of infection control-such as goals, education, documentation, monitoring, accountability, and compliance with policies-are standardized throughout the facility.
For example, if the facility has a problem with safe injection practice, analysis might reveal that the source is related to monitoring and accountability; it would therefore not be in the facility's best interest to spend resources on, say, education or policy and procedure revisions. This type of analysis can also provide the evidence needed to justify or prioritize resources for implementation of infection control strategies. One good example of a practice analysis tool, Monitoring the Use of Evidence-Based Best Practices for Prevention of Healthcare-Associated Infections (HAIs) in Ambulatory Surgery, can be found on the Pennsylvania Patient Safety Authority Web site at http://bit.ly/1n6A96U. The ICSW is another valuable tool for assessing compliance with the CMS ASC infection control conditions for coverage because the DHHS action plan calls for 100% compliance with the process measures laid out in the worksheet.
References