INFECTION CONTROL STANDARDS

http://www.infectioncontroltoday.com/articles/2009/07/new-infection-control-requirements-for-ascs-what.aspx

OBJECTIVES

Identify standards where you can find them; interpretive

guidelines

Describe with confidence how you can meet the standards

Identify Key aspects to stay in compliance

INTRODUCTION

On Nov. 18, 2008 the Centers for Medicare & Medicaid Services (CMS) adopted the Hospital Outpatient Prospective Payment System final rule (73 FR 68502), which included revisions to the ambulatory surgery center Conditions for Coverage (CfCs) in 42 CFR 416.2 – 416.52

This change took effect on May 18, 2009. Included in the new CfCs is a rigorous focus on demonstrated infection prevention and control knowledge and practice in an ASC.

INFECTION PREVENTION AND CONTROL

The primary goal for CMS and the ASC Industry is to assure a safe environment for patients their families, visitors, physicians and staff.

GUIDE TO THE MEDICARE CONDITIONS FOR COVERAGE FOR ASCS

State Operations Manual: Appendix L - Guidance for Surveyors: Ambulatory Surgical Centers (Rev. 76, 12-22-11) Mentions “Infection” 133 times throughout the document.

1. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf

2. www.ascassociation.org/coverage

§416.42 CONDITION FOR COVERAGE: SURGICAL SERVICES

From the very beginning of the document: Surgical procedures must be performed in a “safe manner”… Acceptable standards of practice include maintaining

compliance with applicable Federal and State laws, regulations and guidelines governing surgical services, as well as, any standards and recommendations promoted by or established by nationally recognized professional organizations (e.g., the American Medical Association, American College of Surgeons, Association of Operating Room Nurses, Association for Professionals in Infection Control and Epidemiology, etc.).

SAFE MANNER

Conducting surgery in a “safe manner” also requires appropriate use of liquid germicides in the operating or procedure room. Although the CDC has stated that there are no definitive studies comparing the

effectiveness of the different types of skin antiseptics in preventing SSI, it also states that “Alcohol is readily available, inexpensive, and remains the most effective and rapid-acting skin antiseptic.” Therefore, since alcohol is very effect as a skin antiseptic, there is a need to balance the risks of fire related to use of alcohol-based skin preparations with the risk of surgical site infection.

Fortunately, surgical fires are rare: They occur in only an extremely small percentage of the approximately 65 million surgical cases each year. ECRI has extrapolating from data published by the Pennsylvania Patient Safety Authority in 2007, estimating that 550 to 650 surgical fires occur nationally each year, making the frequency of their occurrence comparable to that of other surgical mishaps (e.g., wrong-site surgery or retained instruments).

SIDE BAR: ALCOHOL PREPS

“Appendix L” goes on to say…The use of an alcohol-based skin preparation in ASCs is not considered “safe,” unless appropriate fire risk reduction measures are taken, preferably as part of a systematic approach by the ASC to preventing surgery-related fires.

A review of recommendations produced by various expert organizations concerning use of alcohol-based skin preparations in anesthetizing locations indicates there is general consensus that the following fire risk reduction measures are appropriate when…

Using skin prep solutions that are: 1) packaged to ensure controlled delivery to the patient in unit dose applicators, swabs, or other similar applicators; and 2) provide clear and explicit manufacturer/supplier instructions and warnings.

These instructions for use should be carefully followed: Ensuring that the alcohol-based skin prep solution does not soak into the patient’s hair or linens.

Sterile towels should be placed to absorb drips and runs during application and should then be removed from the anesthetizing location prior to draping the patient;

Ensuring that the alcohol-based skin prep solution is completely dry prior to draping. This may take a few minutes or more, depending on the amount and location of the solution. The prepped area should be inspected to confirm it is dry prior to draping; and

Verifying that all of the above has occurred prior to initiating the surgical procedure. This can be done, for example, as part of a standardized pre-operative “time out” used to verify other essential information to minimize the risk of medical errors during the procedure.

ASCs that employ alcohol-based skin preparations in ORs or procedure rooms should establish appropriate policies and procedures to reduce the associated risk of fire. They should also document the implementation of these policies and procedures in the patient’s medical record.

INFECTION CONTROL STANDARDS AND WHAT THEY SAY

§416.51 Condition for Coverage – Infection control The ASC must maintain an infection control program

that seeks to minimize infections and communicable diseases.

This requires the ASC to maintain an active program for the minimization of infections and communicable diseases.

DEFINITION

The National Institute of Allergy and Infectious Diseases (NIAID) defines An infectious disease as a change from a state of health to a

state in which part or all of a host’s body cannot function normally because of the presence of an infectious agent or its product.

An infectious agent is a living or quasi-living organism or particle that causes an infectious disease, and includes bacteria, viruses, fungi, protozoa, helminthes, and prions.

A communicable disease as a disease associated with an agent that can be transmitted from one host to another.

THE ASC’S INFECTION CONTROL PROGRAM MUST:

Provide a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases

THE ASC’S INFECTION CONTROL PROGRAM MUST:

Be based on nationally recognized infection control guidelines

Be directed by a designated health care professional with training in infection control;

Be integrated into the ASC’s QAPI program and Be ongoing

THE ASC’S INFECTION CONTROL PROGRAM

How do we that?

Documentation: an ongoing QI program identifies problems [events, policies or practices] or potential problems.

THE ASC’S INFECTION CONTROL PROGRAM MUST:

Include actions to prevent, identify and manage infections and communicable diseases, and

Include a mechanism to immediately implement corrective actions and preventive measures that improve the control of infection within the ASC

§416.51(a) STANDARD: SANITARY ENVIRONMENT

The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. Techniques for food sanitation if employee food

storage and eating areas are provided; Techniques for cleaning and disinfecting

environmental surfaces, carpeting, and furniture; although the standard doesn’t mention it, computers are a new hot topic

Techniques for disposal of regulated and non-regulated waste; and

Techniques for pest control.

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

The ASC must have documentation/practice that indicates the use of a professionally recognized standards of infection control practice. [Reference your policies] Examples of national organizations are:

The Centers for Disease Control and Prevention (CDC), The Association for Professionals in Infection Control and Epidemiology (APIC),

The Society for Healthcare Epidemiology of America (SHEA),

The Association of periOperative Registered Nurses (AORN).

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

Survey Procedures §416.51(a) include: Observe throughout the ASC the cleanliness of the waiting

area(s), the recovery room(s), the OR/procedure rooms, floors, horizontal surfaces, patient equipment, air inlets, mechanical rooms, supply, storage areas, etc.

Interview staff to determine whether cleaning/disinfection takes place at the appropriate frequencies, using suitable EPA-registered agents. Ask for supporting documentation to confirm what staff say in interviews.

Determine whether the ASC has a procedure for decontamination after gross spills of blood or other bodily fluids.

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

Survey Procedures §416.51(a) include: Review monitoring logs for:

housekeeping, maintenance (including repair, renovation,

and construction activities), and other activities to ensure a functional and

sanitary environment.

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

Policies and procedures for a sanitary and functional environment should address the following: Ventilation and water quality control issues, including

measures taken to maintain a safe environment during internal or external construction/renovation;

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

Policies and procedures for a sanitary and functional environment should address the following: Maintaining safe air handling systems in areas of special

ventilation, such as operating rooms; procedures is administered at the appropriate time, done with an appropriate antibiotic, and discontinued appropriately after surgery; - Addressing aseptic technique practices used in surgery, including sterilization or high-level disinfection of instruments, as appropriate;

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

Policies and procedures for a sanitary and functional environment should address the following: Other ASC healthcare-associated infection risk mitigation measures:

Promotion of hand hygiene among staff and employees, including utilization of alcohol-based hand sanitizers;

Measures specific to the prevention of infections caused by organisms that are antibiotic-resistant;

Measures specific to safe practices for injecting medications and saline or other infuscate;

Requiring disinfectants and germicides to be used in accordance with the manufacturers’ instructions;

Appropriate use of facility and medical equipment, including air filtration equipment, UV lights, and other equipment used to control the spread of infectious agents;

Educating patients, visitors, and staff, as appropriate, about infections and communicable diseases and methods to reduce transmission in the ASC and in the community

RISK MITIGATION DOCUMENT

A systematic reduction in the extent of exposure to a risk and/or the likelihood of its occurrence. Also known as risk reduction.

INFECTION PREVENTION RISK ASSESSMENT TOOL FOR RISK MITIGATION

Date: City, State: Brief Description of Your Community: Types of Patient Served: Most Common Diagnoses: Most Common Procedures Performed: Types of Health Concerns that Exist in the Community: Patients at an Increased Risk of Infection: Characteristics that may influence the risk of surgical site infections Patient Operative characteristics Based on this Data, what Patients and Procedures are at the highest risk for infections: The majority of the patient population is at a slightly elevated risk; however special attention will be paid to the diabetic patient, the smokers,

and the patient’s with a greater than 35 BMI. Plan of Action Strategies to Reduce Infection Risk Interventions to Reduce Infection Risk Goals Identified Resources Needed to Accomplish Goals Presented to the Quality committee Presented to the Governing Board Signature of the chair

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

Identifying Infections The ASC must:

Conduct monitoring activities throughout the entire facility in order to identify infection risks or communicable disease problems.

Document its monitoring/tracking activities, including the measures selected for monitoring, and collection and analysis methods.

Use recognized infection control surveillance practices, such as, CDC’s National Healthcare Safety Net (NHSN) APIC standards, AORN recommended standards

Monitoring should include follow-up of patients after discharge [to gather evidence of whether they have developed an infection associated with their stay in the ASC]

STANDARD § 416.51(a): SANITARY ENVIRONMENT

The ASC must provide a safe environment for treating patients, including adequate safeguards to protect the patient from cross-infection by

• adequate space, • adequate equipment to preform the procedure, • adequate supplies, and • adequate personnel.

§416.51(a) STANDARD: SANITARY ENVIRONMENT [CONT]

The ASC must develop and implement appropriate infection control interventions to address issues identified through: Detection activities, Document monitoring of the effectiveness of

interventions through further data collection and analysis.

MONITORING

Monitoring Compliance It is not sufficient for the ASC to have detailed policies and

procedures governing infection control. The ASC must demonstrate that it has a process in place for regularly assessing infection control compliance.

There should be documentation of steps to determine whether the staff adhere to these policies and procedures in practice.

Example: Are staff washing their hands prior to providing care to patients? Do personnel who prepare injections comply with all pertinent protocols? Is equipment properly sterilized or disinfected? Is the facility clean?

§416.51(b) STANDARD: INFECTION CONTROL PROGRAM

The program is under the direction of a designated and qualified professional who has training in infection control.

WHAT DOES IT MEAN TO BE DESIGNATED AND QUALIFIED

The interpretive guidelines defines: §416.51(b) (1) The ASC must designate in writing, a

qualified licensed health care professional who will lead the facility’s infection control program

The ASC must determine and document that the individual has had training in the principles and methods of infection control; and has training that qualifies the individual to lead an infection control program.

§416.51(b) (1) QUALIFICATIONS [FURTHER DESCRIPTION]

This person must: have training that qualifies the individual to lead an infection control

program. maintain his/her qualifications through ongoing education and training,

which can be demonstrated by participation in infection control courses, or in local and national meetings organized by recognized professional societies, such as APIC and SHEA.

Although CMS does not specify the number of hours that the qualified individual must devote to the infection control program, Resources must be adequate to accomplish the tasks required for the infection control program.

The ASC should consider the type of surgical services offered at the facility as well as the patient population in determining the size and scope of the resources it commits to infection control.

§416.51(b) (1) QUALIFICATIONS [EMPHASIZE]

Remember this person needs to be designated by the governing body and there must be documentation that the individual is qualified through ongoing education, training, or certification to oversee the infection control program.

To note: the standards do not dictate what kind of training, but every surveyors has preferences. Just make sure the ASC has the documentation to validate evidence of training.

SURVEY PROCEDURES §416.51(b) (1)

The surveyor will review personnel records to determine whether the designated person is qualified through ongoing education, training or certification to oversee the infection control program.

§416.51(b) (2) STANDARD: INFECTION CONTROL PROGRAM

The program is an integral part of the ASC’s quality assessment and performance improvement program.

SURVEY PROCEDURES §416.51(b) (2)

The surveyor, in order to reflect the importance of infection control in the regulations, will need to review quality documents; these documents must identify that the ICP is integrated into its Quality Assurance/Performance Improvement program.

The documents must show that the infection control data and program activities are an ongoing component the Quality program

SURVEY PROCEDURES §416.51(b) (2)

The ASC must identify that actions are taken in response to data analyses to improve the ASC’s infection control performance.

§416.51(b) (3)

The program is responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.

SURVEY PROCEDURES §416.51(b) (3)

The surveyor must find documentation that the ASC’s infection control professional develops and has implemented a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases within the ASC.

The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the ASC’s infection control outcomes.

The plan should be specific to each particular area of the ASC, including, but not limited to, the waiting room(s), the recovery room(s), and the surgical areas.

The designated infection control professional must assure that the program’s plan of action addresses the maintenance of a sanitary environment

STANDARD § 416.44 (a)(3)

The ASC must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results.

Adherence to Standard 416.44 (a)(3) stated earlier, the ASC must establish a program that reduces the risk of health-care acquired infection through education of the staff and active surveillance activities.

STANDARD § 416.44 (a)(3) SURVEY PROCEDURES

May include: Ask the ASC’s leadership how it tracks infections among

patients and staff. Ask for documentation of this tracking – is there tracking of

all patients? Ask the ASC’s leadership what diseases are reportable to

the State to verify the ASC’s awareness of applicable reporting requirements.

Ask the ASC if it has ever reported a reportable disease to the State? If yes, review the ASC’s documentation of the case.

OTHER COMPLIANCE METHODS

Utilization of WHO, CDC, APIC, AORN, just to name a few, have online education, guidelines and posters for hand hygiene, safe injection practices and standards for sterilization.

Procedures must be available to minimize the sources and transmission of infections.

This includes: Proper hand hygiene along with proper use of gloves. Utilization of single use medications and/or proper use of

multi-dose vials.

APPROPRIATE CLEANING/STERILIZATION TECHNIQUES ARE IMPLEMENT

• ORs must be cleaned and disinfected after each surgical or invasive procedure with an EPA-registered disinfectant

• OR must be terminally cleaned daily• High touch surfaces in patient care areas are cleaned and

disinfected with an EPA-registered disinfectant• A procedure should be in place regarding gross spills of

blood

CMS WORKSHEET

Exhibit 351: Ambulatory Surgical Center

INFECTION CONTROL SURVEYOR WORKSHEET

(Rev. 68 Issued: 11-24-10, Effective: 11-24-10, Implementation: 11-24-10)

CMS WORKSHEET

Part One ASC Characteristics

Primary specialty and then "all” secondary Adults/Pediatric Number of rooms/number of cases Contracted employees or staff

How are the staff trained, including Medical staff Description of Infection Control/Prevention Program

Guidelines used Designated Infection Control individual

PART 2

Specific infection control and related Practices Hand Hygiene and glove usage Injection practices Single use devices, Sterilization and high level

disinfection Environmental Infection Control Point of care [glucometer & INR]

SUMMARY

Identify standards where you can find them; interpretive

guidelines

Describe with confidence how you can meet the standards

Identify Key aspects to stay in compliance

THANK YOU!

Any questions???