Infection Prevention and Control Assessment Tool for Outpatient Settings

This tool is intended to assist in the assessment of infection control programs and practices in outpatient settings. In order to complete the assessment, direct observation of infection control practices will be necessary. To facilitate the assessment, health departments are encouraged to share this tool with facilities in advance of their visit.

Please note, Not Applicable should only be checked if the element or domain is not applicable to the types of services provided by the facility (e.g., the facility never performs point-of-care testing, controlled substances are never kept at the facility). If a particular service is provided by the facility but is unable to be observed during the visit (e.g., no injections were prepared or administered during the visit) that section should still be completed by interviewing relevant personnel about their practices.

Overview V2-3

Section 1: Facility Demographics

Section 2: Infection Control Program and Infrastructure

Section 3: Direct Observation of Facility Practices

Section 4: Infection Control Guidelines and Other Resources

Infection Control Domains for Gap Assessment

Infection Control Program and Infrastructure

Infection Control Training and Competency

Healthcare Personnel Safety

Surveillance and Disease Reporting

V.a/b.	Hand Hygiene

VI.a/b.	Personal Protective Equipment (PPE)

VII.a/b.	Injection Safety (if applicable)

VIII.a/b.	Respiratory Hygiene/Cough Etiquette

IX.a/b.	Point-of-Care Testing (if applicable)

X.a/b.	Environmental Cleaning

XI.a/b.	Device Reprocessing

Sterilization of Reusable Devices (if applicable)

High-level Disinfection of Reusable Devices (if applicable)

Section 1: Facility Demographics
Facility Name (for health department use only)	Click here to enter text.
NHSN Facility Organization ID (for health department use only)	Click here to enter text.
State-assigned Unique ID	Click here to enter text.
Date of Assessment	Click here to enter a date.
Type of Assessment	☐ On-site ☐ Other (specify): Click here to enter text.
Rationale for Assessment (Select all that apply)	☐ Outbreak ☐ Input from accrediting organization or state survey agency ☐ Other (specify): Click here to enter text.
Is the facility licensed by the state?	☐ Yes ☐ No
Is the facility certified by the Centers for Medicare & Medicaid Services (CMS)?	☐ Yes ☐ No
Is the facility accredited?	☐ Yes ☐ No If yes, list the accreditation organization: ☐ Accreditation Association for Ambulatory Health Care (AAAHC) ☐ American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) ☐ American Osteopathic Association (AOA) ☐ The Joint Commission (TJC) ☐ Other (specify): Click here to enter text.
Is the facility affiliated with a hospital?	☐ Yes (specify – for health department use only): Click here to enter text. ☐ No
Which procedures are performed by the facility? Select all that apply.	☐ Chemotherapy	☐ Endoscopy	☐ Ear/Nose/Throat
☐ Imaging (MRI/CT)	☐ Immunizations	☐ OB/Gyn
☐ Ophthalmologic	☐ Orthopedic	☐ Pain remediation
☐ Plastic/reconstructive	☐ Podiatry	☐ Other (specify): Click here to enter text.
What is the primary procedure-type performed by the facility? Select only one.	☐ Chemotherapy	☐ Endoscopy	☐ Ear/Nose/Throat
☐ Imaging (MRI/CT)	☐ Immunizations	☐ OB/Gyn
☐ Ophthalmologic	☐ Orthopedic	☐ Pain remediation
☐ Plastic/reconstructive	☐ Podiatry	☐ Other (specify): Click here to enter text.
How many physicians work at the facility?	Click here to enter text.
What is the average number of patients seen per week?	Click here to enter text.

Section 2: Infection Control Program and Infrastructure

Infection Control Program and Infrastructure
Elements to be assessed	Assessment	Notes/Areas for Improvement
Written infection prevention policies and procedures are available, current, and based on evidence-based guidelines (e.g., CDC/HICPAC), regulations, or standards. Note: Policies and procedures should be appropriate for the services provided by the facility and should extend beyond OSHA bloodborne pathogens training	Yes No	Click here to enter text.
Infection prevention policies and procedures are re-assessed at least annually or according to state or federal requirements, and updated if appropriate.	Yes No	Click here to enter text.
At least one individual trained in infection prevention is employed by or regularly available (e.g., by contract) to manage the facility’s infection control program. Note: Examples of training may include: Successful completion of initial and/or recertification exams developed by the Certification Board for Infection Control & Epidemiology; participation in infection control courses organized by the state or recognized professional societies (e.g., APIC, SHEA).	Yes No	Click here to enter text.
Facility has system for early detection and management of potentially infectious persons at initial points of patient encounter. Note: System may include taking a travel and occupational history, as appropriate, and elements described under respiratory hygiene/cough etiquette.	Yes No	Click here to enter text.

Infection Control Training and Competency
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility has a competency-based training program that provides job-specific training on infection prevention policies and procedures to healthcare personnel. Note: This includes those employed by outside agencies and available by contract or on a volunteer basis to the facility. See sections below for more specific assessment of training related to: hand hygiene, personal protective equipment (PPE), injection safety, environmental cleaning, point-of-care testing, and device reprocessing	Yes No	Click here to enter text.

Healthcare Personnel Safety
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility has an exposure control plan that is tailored to the specific requirements of the facility (e.g., addresses potential hazards posed by specific services provided by the facility). Note: A model template, which includes a guide for creating an exposure control plan that meets the requirements of the OSHA Bloodborne Pathogens Standard is available at: https://www.osha.gov/Publications/osha3186.pdf	Yes No	Click here to enter text.
HCP for whom contact with blood or other potentially infectious material is anticipated are trained on the OSHA bloodborne pathogens standard upon hire and at least annually.	Yes No	Click here to enter text.
Following an exposure event, post-exposure evaluation and follow-up, including prophylaxis as appropriate, are available at no cost to employee and are supervised by a licensed healthcare professional. Note: An exposure incident refers to a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an individual’s duties.	Yes No	Click here to enter text.
Facility tracks HCP exposure events and evaluates event data and develops/implements corrective action plans to reduce incidence of such events.	Yes No	Click here to enter text.
Facility follows recommendations of the Advisory Committee on Immunization Practices (ACIP) for immunization of HCP, including offering Hepatitis B and influenza vaccination. Note: Immunization of Health-Care Personnel: Recommendations of the ACIP available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm	Yes No	Click here to enter text.
All HCP receive baseline tuberculosis (TB) screening prior to placement; HCP receive repeat testing, if appropriate, based on the facility-level risk assessment. Note: For more information, facilities should refer to the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm?s_cid=rr5417a1_e	Yes No	Click here to enter text.
If respirators are used, the facility has a respiratory protection program that details required worksite-specific procedures and elements for required respirator use, including provision of medical clearance, training, and fit testing as appropriate.	Yes No Not Applicable	Click here to enter text.
Facility has well-defined policies concerning contact of personnel with patients when personnel have potentially transmissible conditions. These policies include:	Yes No	Click here to enter text.
Work-exclusion policies that encourage reporting of illnesses and do not penalize with loss of wages, benefits, or job status.	Yes No	Click here to enter text.
Education of personnel on prompt reporting of illness to supervisor.	Yes No	Click here to enter text.
Surveillance and Disease Reporting
Elements to be assessed	Assessment	Notes/Areas for Improvement
An updated list of diseases reportable to the public health authority is readily available to all personnel.	Yes No	Click here to enter text.
Facility can demonstrate knowledge of and compliance with mandatory reporting requirements for notifiable diseases, healthcare associated infections (as appropriate), and for potential outbreaks.	Yes No	Click here to enter text.
Patients who have undergone procedures at the facility are educated regarding signs and symptoms of infection that may be associated with the procedure and instructed to notify the facility if such signs or symptoms occur.	Yes No	Click here to enter text.

V.a. Hand Hygiene
Elements to be assessed	Assessment	Notes/Areas for Improvement
All HCP are educated regarding appropriate indications for hand hygiene: Upon hire, prior to provision of care	Yes No	Click here to enter text.
Annually	Yes No	Click here to enter text.
HCP are required to demonstrate competency with hand hygiene following each training	Yes No	Click here to enter text.
Facility routinely audits (monitors and documents) adherence to hand hygiene.	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their hand hygiene performance.	Yes No	Click here to enter text.
Hand hygiene policies promote preferential use of alcohol-based hand rub (ABHR) over soap and water in most clinical situations. Note: Soap and water should be used when hands are visibly soiled (e.g., blood, body fluids) and is also preferred after caring for a patient with known or suspected C. difficile or norovirus during an outbreak.	Yes No	Click here to enter text.

VI.a. Personal Protective Equipment (PPE)
Elements to be assessed	Assessment	Notes/Areas for Improvement
HCP who use PPE receive training on proper selection and use of PPE: Upon hire, prior to provision of care	Yes No	Click here to enter text.
Annually	Yes No	Click here to enter text.
When new equipment or protocols are introduced	Yes No	Click here to enter text.
HCP are required to demonstrate competency with selection and use of PPE following each training.	Yes No	Click here to enter text.
Facility routinely audits (monitors and documents) adherence to proper PPE selection and use.	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their performance with selection and use of PPE.	Yes No	Click here to enter text.

VII.a. Injection Safety (This element does not include assessment of pharmacy/compounding practices) If injectable medications are never prepared or administered at the facility check Not Applicable here and skip to Section VIII.a. Respiratory Hygiene/Cough Etiquette.
Elements to be assessed	Assessment	Notes/Areas for Improvement
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: Upon hire, prior to being allowed to prepare and/or administer parenteral medications	Yes No	Click here to enter text.
Annually	Yes No	Click here to enter text.
When new equipment or protocols are introduced	Yes No	Click here to enter text.
HCP are required to demonstrate competency with safe injection practices following each training.	Yes No	Click here to enter text.
Facility routinely audits (monitors and documents) adherence to safe injection practices.	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their adherence to safe injection practices.	Yes No	Click here to enter text.
Facility has policies and procedures to track HCP access to controlled substances to prevent narcotics theft/diversion. Note: Policies and procedures should address: how data are reviewed, how facility would respond to unusual access patterns, how facility would assess risk to patients if tampering (alteration or substitution) is suspected or identified, and who the facility would contact if diversion is suspected or identified.	Yes No Not Applicable (Facility does not prepare or administer controlled substances)	Click here to enter text.

VIII.a. Respiratory Hygiene/Cough Etiquette
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility has policies and procedures to contain respiratory secretions in persons who have signs and symptoms of a respiratory infection, beginning at point of entry to the facility and continuing through the duration of the visit. Policies include:	Yes No	Click here to enter text.
Offering facemasks to coughing patients and other symptomatic persons upon entry to the facility, at a minimum, during periods of increased respiratory infection activity in the community.	Yes No	Click here to enter text.
Providing space in waiting rooms and encouraging persons with symptoms of respiratory infections to sit as far away from others as possible. Note: If available, facilities may wish to place patients with symptoms of a respiratory infection in a separate area while waiting for care.	Yes No	Click here to enter text.
Facility educates HCP on the importance of infection prevention measures to contain respiratory secretions to prevent the spread of respiratory pathogens.	Yes No	Click here to enter text.

IX.a. Point-of-Care Testing (e.g., blood glucose meters, INR monitor) If point-of-care testing is never performed at the facility check Not Applicable here and skip to Section X.a. Environmental Cleaning
Elements to be assessed	Assessment	Notes/Areas for Improvement
HCP who perform point-of-care testing receive training on recommended practices: Upon hire, prior to being allowed to perform point-of-care testing	Yes No	Click here to enter text.
Annually	Yes No	Click here to enter text.
When new equipment or protocols are introduced	Yes No	Click here to enter text.
HCP are required to demonstrate competency with recommended practices for point-of-care testing following each training.	Yes No	Click here to enter text.
Facility routinely audits (monitors and documents) adherence to recommended practices during point-of-care testing.	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their adherence to recommended practices.	Yes No	Click here to enter text.

X.a. Environmental Cleaning
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility has written policies and procedures for routine cleaning and disinfection of environmental surfaces, including identification of responsible personnel.	Yes No	Click here to enter text.
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures Upon hire, prior to being allowed to perform environmental cleaning	Yes No	Click here to enter text.
Annually	Yes No	Click here to enter text.
When new equipment or protocols are introduced Note: If environmental cleaning is performed by contract personnel, facility should verify this is provided by contracting company.	Yes No	Click here to enter text.
HCP are required to demonstrate competency with environmental cleaning procedures following each training.	Yes No	Click here to enter text.
Facility routinely audits (monitors and documents) adherence to cleaning and disinfection procedures, including using products in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their adherence to cleaning and disinfection procedures.	Yes No	Click here to enter text.
Facility has a policy/procedure for decontamination of spills of blood or other body fluids.	Yes No	Click here to enter text.

X.a. Environmental Cleaning, continued
Operating Room For the purposes of this checklist, an operating room is defined as a patient care area that met the Facilities Guidelines Institute’s (FGI) or American Institute of Architects’ (AIA) criteria for an operating room when it was constructed or renovated. This is the same definition that is used in the National Healthcare Safety Network’s Procedure-associated Module for the SSI Event (http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf) If the facility does not have an operating room check Not Applicable here and skip to section XI.a. Device Reprocessing
Elements to be assessed	Assessment	Notes/Areas for Improvement
Operating rooms are terminally cleaned after last procedure of the day.	Yes No	Click here to enter text.
Facility routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to preoperative surgical scrub and hand hygiene	Yes No	Click here to enter text.
Appropriate use of surgical attire and drapes	Yes No	Click here to enter text.
Adherence to aseptic technique and sterile field	Yes No	Click here to enter text.
Proper ventilation requirements in surgical suites	Yes No	Click here to enter text.
Minimization of traffic in the operating room	Yes No	Click here to enter text.
Adherence to cleaning and disinfection of environmental surfaces	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their adherence to surgical infection prevention practices.	Yes No	Click here to enter text.

XI.a. Device Reprocessing The following basic information allows for a general assessment of policies and procedures related to reprocessing of reusable medical devices. Outpatient facilities that are performing on-site sterilization or high-level disinfection of reusable medical devices should refer to the more detailed checklists in separate sections of this document devoted to those issues. Categories of Medical Devices: Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior to use (see Sterilization Section). Semi-critical items (e.g., endoscopes for upper endoscopy and colonoscopy, vaginal probes) are objects that contact mucous membranes or non-intact skin and require, at a minimum, high-level disinfection prior to reuse (see High-level Disinfection Section). Non-critical items (e.g., blood pressure cuffs) are objects that may come in contact with intact skin but not mucous membranes and should undergo cleaning and low- or intermediate-level disinfection depending on the nature and degree of contamination. Single-use devices (SUDs) are labeled by the manufacturer for a single use and do not have reprocessing instructions. They may not be reprocessed for reuse except by entities which have complied with FDA regulatory requirements and have received FDA clearance to reprocess specific SUDs. Note: Cleaning must always be performed prior to sterilization and disinfection
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility has policies and procedures to ensure that reusable medical devices are cleaned and reprocessed appropriately prior to use on another patient. Note: This includes clear delineation of responsibility among HCP for cleaning and disinfection of equipment including, non-critical equipment, mobile devices, and other electronics (e.g., point-of-care devices) that might not be reprocessed in a centralized reprocessing area.	Yes No	Click here to enter text.
The individual(s) in charge of infection prevention at the facility is consulted whenever new devices or products will be purchased or introduced to ensure implementation of appropriate reprocessing policies and procedures.	Yes No	Click here to enter text.
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: Upon hire, prior to being allowed to reprocess devices	Yes No	Click here to enter text.
Annually	Yes No	Click here to enter text.
When new devices are introduced or policies/procedures change. Note: If device reprocessing is performed by contract personnel, facility should verify this is provided by contracting company.	Yes No	Click here to enter text.
HCP are required to demonstrate competency with reprocessing procedures (i.e., correct technique is observed by trainer) following each training.	Yes No	Click here to enter text.

XI.a. Device Reprocessing, continued
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility routinely audits (monitors and documents) adherence to reprocessing procedures.	Yes No	Click here to enter text.
Facility provides feedback from audits to personnel regarding their adherence to reprocessing procedures.	Yes No	Click here to enter text.
Facility has protocols to ensure that HCP can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in designated area).	Yes No	Click here to enter text.
Facility has policies and procedures outlining facility response (i.e., risk assessment and recall of device) in the event of a reprocessing error or failure.	Yes No	Click here to enter text.
Routine maintenance for reprocessing equipment (e.g., automated endoscope reprocessors, steam autoclave) is performed by qualified personnel in accordance with manufacturer instructions; confirm maintenance records are available.	Yes No Not Applicable (Reprocessing equipment is not used at the facility)	Click here to enter text.

Section 3: Direct Observation of Facility Practices

Certain infection control lapses (e.g., reuse of syringes on more than one patient or to access a medication container that is used for subsequent patients; reuse of lancets) have resulted in bloodborne pathogen transmission and should be halted immediately. Identification of such lapses warrants appropriate notification and testing of potentially affected patients.

If an element is unable to be observed during an assessment (e.g., no patients received point-of-care testing during the visit), assess the element by interviewing appropriate personnel about facility practices. Notation should also be made in the notes section that the element was not able to be directly observed.

V.b. Hand hygiene
Elements to be assessed	Assessment	Notes/Areas for Improvement
Supplies necessary for adherence to hand hygiene (e.g., soap, water, paper towels, alcohol-based hand rub) are readily accessible to HCP in patient care areas.	Yes No	Click here to enter text.
Hand hygiene is performed correctly:
Before contact with the patient	Yes No	Click here to enter text.
Before performing an aseptic task (e.g., insertion of IV or preparing an injection, administering eye drops)	Yes No Not Applicable	Click here to enter text.
After contact with the patient	Yes No	Click here to enter text.
After contact with objects in the immediate vicinity of the patient	Yes No	Click here to enter text.
After contact with blood, body fluids or contaminated surfaces	Yes No	Click here to enter text.
After removing gloves	Yes No	Click here to enter text.
When moving from a contaminated-body site to a clean-body site during patient care	Yes No Not Applicable	Click here to enter text.

VI.b. Personal Protective Equipment (PPE)
Elements to be assessed	Assessment	Notes/Areas for Improvement
Sufficient and appropriate PPE is available and readily accessible to HCP.	Yes No	Click here to enter text.
PPE is used correctly:
PPE, other than respirator, is removed and discarded prior to leaving the patient’s room or care area. If a respirator is used, it is removed and discarded (or reprocessed if reusable) after leaving the patient room or care area and closing the door.	Yes No	Click here to enter text.
Hand hygiene is performed immediately after removal of PPE.	Yes No	Click here to enter text.

VI.b. Personal Protective Equipment (PPE), continued
Elements to be assessed	Assessment	Notes/Areas for Improvement
Gloves HCP wear gloves for potential contact with blood, body fluids, mucous membranes, non-intact skin, or contaminated equipment.	Yes No	Click here to enter text.
HCP do not wear the same pair of gloves for the care of more than one patient.	Yes No	Click here to enter text.
HCP do not wash gloves for the purpose of reuse.	Yes No	Click here to enter text.
Gowns HCP wear gowns to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated.	Yes No Not Applicable	Click here to enter text.
HCP do not wear the same gown for the care of more than one patient.	Yes No Not Applicable	Click here to enter text.
Facial protection HCP wear mouth, nose, and eye protection during procedures that are likely to generate splashes or sprays of blood or other body fluids.	Yes No Not Applicable	Click here to enter text.

VII.b. Injection safety (This element does not include assessment of pharmacy/compounding practices) If injectable medications are never prepared or administered at the facility check Not Applicable here and skip to Section VIII.b. Respiratory Hygiene/Cough Etiquette
Elements to be assessed	Assessment	Notes/Areas for Improvement
Injections are prepared using aseptic technique in a clean area free from contamination or contact with blood, body fluids or contaminated equipment.	Yes No	Click here to enter text.
Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and cartridge devices such as insulin pens).	Yes No	Click here to enter text.
The rubber septum on a medication vial is disinfected with alcohol prior to piercing.	Yes No	Click here to enter text.
Medication containers are entered with a new needle and a new syringe, even when obtaining additional doses for the same patient.	Yes No	Click here to enter text.
Single dose (single-use) medication vials, ampules, and bags or bottles of intravenous solution are used for only one patient.	Yes No	Click here to enter text.
Medication administration tubing and connectors are used for only one patient.	Yes No Not Applicable (Facility does not use tubing or connectors)	Click here to enter text.
Multi-dose vials are dated by HCP when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Note: This is different from the expiration date printed on the vial.	Yes No Not Applicable (Facility does not use multi-dose vials or discards them after single patient use)	Click here to enter text.

VII.b. Injection safety (This element does not include assessment of pharmacy/compounding practices), continued
Elements to be assessed	Assessment	Notes/Areas for Improvement
Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle). Note: If multi-dose vials enter the immediate patient treatment area they should be dedicated for single-patient use and discarded immediately after use.	Yes No Not Applicable (Facility does not use multi-dose vials or discards them after single patient use)	Click here to enter text.
All sharps are disposed of in a puncture-resistant sharps container.	Yes No	Click here to enter text.
Filled sharps containers are disposed of in accordance with state regulated medical waste rules.	Yes No	Click here to enter text.
All controlled substances (e.g., Schedule II, III, IV, V drugs) are kept locked within a secure area.	Yes No Not Applicable (Controlled substances are not kept at the facility)	Click here to enter text.
HCP wear a facemask (e.g., surgical mask) when placing a catheter or injecting material into the epidural or subdural space (e.g., during myelogram, epidural or spinal anesthesia).	Yes No Not Applicable (Facility does not perform spinal injection procedures)	Click here to enter text.

VIII.b. Respiratory Hygiene/Cough Etiquette
Elements to be assessed	Assessment	Notes/Areas for Improvement
Facility: Posts signs at entrances with instructions to patients with symptoms of respiratory infection to: Inform HCP of symptoms of a respiratory infection when they first register for care, and Practice Respiratory Hygiene/Cough Etiquette (cover their mouths/noses when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after hands have been covered with respiratory secretions).	Yes No	Click here to enter text.
Provides tissues and no-touch receptacles for disposal of tissues.	Yes No	Click here to enter text.
Provides resources for performing hand hygiene in or near waiting areas.	Yes No	Click here to enter text.

IX.b. Point-of-Care Testing (e.g., blood glucose meters, INR monitor) If point-of-care testing is never performed at the facility check Not Applicable here and skip to Section X.b. Environmental Cleaning
Elements to be assessed	Assessment	Notes/Areas for Improvement
New single-use, auto-disabling lancing device is used for each patient. Note: Lancet holder devices are not suitable for multi-patient use.	Yes No Not Applicable	Click here to enter text.
If used for more than one patient, the point-of-care blood testing meter is cleaned and disinfected after every use according to manufacturer’s instructions. Note: If the manufacturer does not provide instructions for cleaning and disinfection, then the testing meter should not be used for >1 patient.	Yes No Not Applicable	Click here to enter text.

X.b. Environmental Cleaning
Elements to be assessed	Assessment	Notes/Areas for Improvement
Supplies necessary for appropriate cleaning and disinfection procedures (e.g., EPA-registered disinfectants) are available. Note: If environmental services are performed by contract personnel, facility should verify that appropriate EPA-registered products are provided by contracting company	Yes No	Click here to enter text.
High-touch surfaces in rooms where surgical or other invasive procedures (e.g., endoscopy, spinal injections) are performed are cleaned and then disinfected with an EPA-registered disinfectant after each procedure.	Yes No Not Applicable	Click here to enter text.
Cleaners and disinfectants are used in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).	Yes No	Click here to enter text.
HCP engaged in environmental cleaning wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection). Note: The exact type of correct PPE depends on infectious or chemical agent and anticipated type of exposure.	Yes No	Click here to enter text.

XI.b. Device Reprocessing
Elements to be assessed	Assessment	Notes/Areas for Improvement
Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the facility are available in the reprocessing area(s).	Yes No	Click here to enter text.
Reusable medical devices are cleaned, reprocessed (disinfection or sterilization) and maintained according to the manufacturer instructions. Note: If the manufacturer does not provide such instructions, the device may not be suitable for multi-patient use.	Yes No	Click here to enter text.
Single-use devices are discarded after use and not used for more than one patient unless they have been appropriately reprocessed as described in the note below. Note: If the facility elects to reuse single-use devices, these devices must be reprocessed prior to reuse by a third-party reprocessor that it is registered with the FDA as a third-party reprocessor and cleared by the FDA to reprocess the specific device in question. The facility should have documentation from the third party reprocessor confirming this is the case.	Yes No	Click here to enter text.
Reprocessing area: Adequate space is allotted for reprocessing activities.	Yes No	Click here to enter text.
A workflow pattern is followed such that devices clearly flow from high contamination areas to clean/sterile areas (i.e., there is clear separation between soiled and clean workspaces).	Yes No	Click here to enter text.
Adequate time for reprocessing is allowed to ensure adherence to all steps recommended by the device manufacturer, including drying and proper storage. Note: Facilities should have an adequate supply of instruments for the volume of procedures performed and should schedule procedures to allow sufficient time for all reprocessing steps.	Yes No	Click here to enter text.
HCP engaged in device reprocessing wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection). Note: The exact type of correct PPE depends on infectious or chemical agent and anticipated type of exposure.	Yes No	Click here to enter text.
Medical devices are stored in a manner to protect from damage and contamination.	Yes No	Click here to enter text.

XII. Sterilization of Reusable Devices If all device sterilization is performed off-site, complete elements M-O and check Not Applicable for the remaining elements in this section. If sterilization of reusable devices is never performed (either at the facility or off-site) check Not Applicable here and skip to Section XIII.
Elements to be assessed	Assessment	Notes/Areas for Improvement
Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to sterilization. Note: Cleaning may be manual (i.e., using friction) and/or mechanical (e.g., with ultrasonic cleaners, washer-disinfector, washer-sterilizers). Ensure appropriately sized cleaning brushes are selected for cleaning device channels and lumens.	Yes No Not Applicable	Click here to enter text.
Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto devices.	Yes No Not Applicable	Click here to enter text.
Enzymatic cleaner or detergent is used for cleaning and discarded according to manufacturer’s instructions (typically after each use)	Yes No Not Applicable	Click here to enter text.
Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer’s instructions) after use.	Yes No Not Applicable	Click here to enter text.
After cleaning, instruments are appropriately wrapped/packaged for sterilization (e.g., package system selected is compatible with the sterilization process being performed, items are placed correctly into the basket, shelf or cart of the sterilizer so as not to impede the penetration of the sterilant, hinged instruments are open, instruments are disassembled if indicated by the manufacturer).	Yes No Not Applicable	Click here to enter text.
A chemical indicator (process indicator) is placed correctly in the instrument packs in every load.	Yes No Not Applicable	Click here to enter text.
A biological indicator, intended specifically for the type and cycle parameters of the sterilizer, is used at least weekly for each sterilizer and with every load containing implantable items.	Yes No Not Applicable	Click here to enter text.
For dynamic air removal-type sterilizers (e.g., prevacuum steam sterilizer), an air removal test (Bowie-Dick test) is performed in an empty dynamic-air removal sterilizer each day the sterilizer is used to verify efficacy of air removal.	Yes No Not Applicable	Click here to enter text.
Sterile packs are labeled with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date.	Yes No Not Applicable	Click here to enter text.
Sterilization logs are current and include results from each load.	Yes No Not Applicable	Click here to enter text.
Immediate-use steam sterilization, if performed, is only done in circumstances in which routine sterilization procedures cannot be performed.	Yes No Not Applicable	Click here to enter text.

XII. Sterilization of Reusable Devices, continued
Elements to be assessed	Assessment	Notes/Areas for Improvement
Instruments that undergo immediate-use steam sterilization are used immediately and not stored.	Yes No Not Applicable	Click here to enter text.
After sterilization, medical devices are stored so that sterility is not compromised.	Yes No Not Applicable	Click here to enter text.
Sterile packages are inspected for integrity and compromised packages are reprocessed prior to use.	Yes No Not Applicable	Click here to enter text.
The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to the off-site reprocessing facility.	Yes No Not Applicable	Click here to enter text.

High-Level Disinfection of Reusable Devices If all high-level disinfection is performed off-site, complete elements L-N below and check Not Applicable for the remaining elements in this section. If high-level disinfection of reusable devices is never performed (either at the facility or off-site) check here: Not Applicable
Elements to be assessed	Assessment	Notes/Areas for Improvement
Flexible endoscopes are inspected for damage and leak tested as part of each reprocessing cycle. Any device that fails the leak test is removed from clinical use and repaired.	Yes No Not Applicable	Click here to enter text.
Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to high-level disinfection. Note: Cleaning may be manual (i.e., using friction) and/or mechanical (e.g., with ultrasonic cleaners, washer-disinfector, washer-sterilizers). Ensure appropriately sized cleaning brushes are selected for cleaning device channels and lumens.	Yes No Not Applicable	Click here to enter text.
Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto instruments.	Yes No Not Applicable	Click here to enter text.
Enzymatic cleaner or detergent is used and discarded according to manufacturer instructions (typically after each use).	Yes No Not Applicable	Click here to enter text.
Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer instructions) after use.	Yes No Not Applicable	Click here to enter text.
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Preparation	Yes No Not Applicable	Click here to enter text.
Testing for appropriate concentration	Yes No Not Applicable	Click here to enter text.
Replacement (i.e., upon expiration or loss of efficacy)	Yes No Not Applicable	Click here to enter text.

XIII. High-Level Disinfection of Reusable Devices, continued
Elements to be assessed	Assessment	Notes/Areas for Improvement
If automated reprocessing equipment (e.g., automated endoscope reprocessor) is used, proper connectors are used to assure that channels and lumens are appropriately disinfected.	Yes No Not Applicable	Click here to enter text.
Devices are disinfected for the appropriate length of time as specified by manufacturer instructions.	Yes No Not Applicable	Click here to enter text.
Devices are disinfected at the appropriate temperature as specified by manufacturer instructions.	Yes No Not Applicable	Click here to enter text.
After high-level disinfection, devices are appropriately rinsed as specified by the manufacturer.	Yes No Not Applicable	Click here to enter text.
Devices are dried thoroughly prior to reuse. Note: For lumened instruments (e.g., endoscopes) this includes flushing all channels with alcohol and forcing air through channels.	Yes No Not Applicable	Click here to enter text.
After high-level disinfection, devices are stored in a manner to protect from damage or contamination. Note: Endoscopes should be hung in a vertical position.	Yes No Not Applicable	Click here to enter text.
Facility maintains a log for each endoscopy procedure which includes: patient’s name and medical record number (if available), procedure, date, endoscopist, system used to reprocess the endoscope (if more than one system could be used in the reprocessing area), and serial number or other identifier of the endoscope used.	Yes No Not Applicable	Click here to enter text.
The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to the off-site reprocessing facility.	Yes No Not Applicable	Click here to enter text.

Section 4: Infection Control Guidelines and Other Resources

General Infection Prevention

☐ CDC/HICPAC Guidelines and recommendations: http://www.cdc.gov/HAI/prevent/prevent_pubs.html

Healthcare Personnel Safety

☐ Guideline for Infection Control in Healthcare Personnel: http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

☐ Immunization of HealthCare Personnel: http://www.cdc.gov/vaccines/spec-grps/hcw.htm

☐ Occupational Safety & Health Administration (OSHA) Bloodborne Pathogens and Needlestick Prevention Standard: http://www.osha.gov/SLTC/bloodbornepathogens/index.html

☐ OSHA Respiratory Protection Standard: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=12716&p_table=STANDARDS

☐ OSHA Respirator Fit Testing: https://www.osha.gov/video/respiratory_protection/fittesting_transcript.html

Hand Hygiene

☐ Guideline for Hand Hygiene in Healthcare Settings: http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf

☐ Hand Hygiene in Healthcare Settings: http://www.cdc.gov/handhygiene/

Examples of tools that can be used to conduct a formal audit of hand hygiene practices:

☐ http://www.jointcommission.org/assets/1/18/hh_monograph.pdf

☐ http://compepi.cs.uiowa.edu/index.php/Research/IScrub

Personal Protective Equipment

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ Guidance for the Selection and Use of Personal Protective Equipment in Healthcare Settings: http://www.cdc.gov/HAI/prevent/ppe.html

Injection Safety

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ CDC Injection Safety Web Materials: http://www.cdc.gov/injectionsafety/

☐ CDC training video and related Safe Injection Practices Campaign materials: http://www.oneandonlycampaign.org/

Respiratory Hygiene/Cough Etiquette

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ Recommendations for preventing the spread of influenza: http://www.cdc.gov/flu/professionals/infectioncontrol/

Environmental Cleaning

☐ Guidelines for Environmental Infection Control in Healthcare Facilities: http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf

☐ Options for Evaluating Environmental Infection Control: http://www.cdc.gov/HAI/toolkits/Evaluating-Environmental-Cleaning.html

Equipment Reprocessing

☐ Guideline for Disinfection and Sterilization in Healthcare Facilities: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

☐ FDA regulations on reprocessing of single-use devices: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071434

Point-of-Care Testing

☐ Infection Prevention during Blood Glucose Monitoring and Insulin Administration: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html

☐ Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration: http://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html

Resources to assist with evaluation and response to breaches in infection control

☐ Patel PR, Srinivasan A, Perz JF. Developing a broader approach to management of infection control breaches in health care settings. Am J Infect Control. 2008 Dec; 36(10); 685-90

http://www.ajicjournal.org/article/S0196-6553(08)00683-4/abstract

☐ Steps for Evaluating an Infection Control Breach: http://www.cdc.gov/hai/outbreaks/steps_for_eval_IC_breach.html

☐ Patient Notification Toolkit: http://www.cdc.gov/injectionsafety/pntoolkit/index.html

Antibiotic Stewardship

☐ Get Smart Programs & Observances: http://www.cdc.gov/getsmart/

Assessment Summary

I. Infection Control Program and Infrastructure
Incomplete Elements
Written infection prevention policies and procedures are available, current, and based on evidence-based guidelines (e.g., CDC/HICPAC), regulations, or standards.
Infection prevention policies and procedures are re-assessed at least annually or according to state or federal requirements, and updated if appropriate.
At least one individual trained in infection prevention is employed by or regularly available (e.g., by contract) to manage the facility’s infection control program.
Facility has system for early detection and management of potentially infectious persons at initial points of patient encounter.
Summary of ‘No’ Responses
Written infection prevention policies and procedures are available, current, and based on evidence-based guidelines (e.g., CDC/HICPAC), regulations, or standards.
Infection prevention policies and procedures are re-assessed at least annually or according to state or federal requirements, and updated if appropriate.
At least one individual trained in infection prevention is employed by or regularly available (e.g., by contract) to manage the facility’s infection control program.
Facility has system for early detection and management of potentially infectious persons at initial points of patient encounter.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

II. Infection Control Training and Competency
Incomplete Elements
Facility has a competency-based training program that provides job-specific training on infection prevention policies and procedures to healthcare personnel.
Summary of ‘No’ Responses
Facility has a competency-based training program that provides job-specific training on infection prevention policies and procedures to healthcare personnel.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

III. Healthcare Personnel Safety
Incomplete Elements
Facility has an exposure control plan that is tailored to the specific requirements of the facility (e.g., addresses potential hazards posed by specific services provided by the facility).
HCP for whom contact with blood or other potentially infectious material is anticipated are trained on the OSHA bloodborne pathogen standard upon hire and at least annually.
Following an exposure event, post-exposure evaluation and follow-up, including prophylaxis as appropriate, are available at no cost to employee and are supervised by a licensed healthcare professional.
Facility tracks HCP exposure events and evaluates event data and develops/implements corrective action plans to reduce incidence of such events.
Facility follows recommendations of the Advisory Committee on Immunization Practices (ACIP) for immunization of HCP, including offering Hepatitis B and influenza vaccination.
All HCP receive baseline tuberculosis (TB) screening prior to placement, and those with potential for ongoing exposure to TB receive periodic screening (if negative) at least annually.
If respirators are used, the facility has a respiratory protection program that details required worksite-specific procedures and elements for required respirator use, including provision of medical clearance, training, and fit testing as appropriate.
Facility has well-defined policies concerning contact of personnel with patients when personnel have potentially transmissible conditions. These policies include:
Work-exclusion policies that encourage reporting of illnesses and do not penalize with loss of wages, benefits, or job status.
Education of personnel on prompt reporting of illness to supervisor.
Summary of ‘No’ Responses
Facility has an exposure control plan that is tailored to the specific requirements of the facility (e.g., addresses potential hazards posed by specific services provided by the facility).
HCP for whom contact with blood or other potentially infectious material is anticipated are trained on the OSHA bloodborne pathogen standard upon hire and at least annually.
Following an exposure event, post-exposure evaluation and follow-up, including prophylaxis as appropriate, are available at no cost to employee and are supervised by a licensed healthcare professional.
Facility tracks HCP exposure events and evaluates event data and develops/implements corrective action plans to reduce incidence of such events.
Facility follows recommendations of the Advisory Committee on Immunization Practices (ACIP) for immunization of HCP, including offering Hepatitis B and influenza vaccination.
All HCP receive baseline tuberculosis (TB) screening prior to placement, and those with potential for ongoing exposure to TB receive periodic screening (if negative) at least annually.
If respirators are used, the facility has a respiratory protection program that details required worksite-specific procedures and elements for required respirator use, including provision of medical clearance, training, and fit testing as appropriate.
Facility has well-defined policies concerning contact of personnel with patients when personnel have potentially transmissible conditions. These policies include:
Work-exclusion policies that encourage reporting of illnesses and do not penalize with loss of wages, benefits, or job status.
Education of personnel on prompt reporting of illness to supervisor.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

IV. Surveillance and Disease Reporting
Incomplete Elements
An updated list of diseases reportable to the public health authority is readily available to all personnel.
Facility can demonstrate knowledge of and compliance with mandatory reporting requirements for notifiable diseases, healthcare associated infections (as appropriate), and for potential outbreaks.
Patients who have undergone procedures at the facility are educated regarding signs and symptoms of infection that may be associated with the procedure and instructed to notify the facility if such signs or symptoms occur.
Summary of ‘No’ Responses
An updated list of diseases reportable to the public health authority is readily available to all personnel.
Facility can demonstrate knowledge of and compliance with mandatory reporting requirements for notifiable diseases, healthcare associated infections (as appropriate), and for potential outbreaks.
Patients who have undergone procedures at the facility are educated regarding signs and symptoms of infection that may be associated with the procedure and instructed to notify the facility if such signs or symptoms occur.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

V. Hand Hygiene
Incomplete Elements
V.a.
All HCP are educated regarding appropriate indications for hand hygiene: Upon hire, prior to provision of care
All HCP are educated regarding appropriate indications for hand hygiene: Annually
HCP are required to demonstrate competency with hand hygiene following each training
Facility routinely audits (monitors and documents) adherence to hand hygiene.
Facility provides feedback from audits to personnel regarding their hand hygiene performance.
Hand hygiene policies promote preferential use of alcohol-based hand rub (ABHR) over soap and water in most clinical situations.
V.b.
Supplies necessary for adherence to hand hygiene (e.g., soap, water, paper towels, alcohol-based hand rub) are readily accessible to HCP in patient care areas.
Before contact with the patient
Before performing an aseptic task (e.g., insertion of IV or preparing an injection, administering eye drops)
After contact with the patient
After contact with objects in the immediate vicinity of the patient
After contact with blood, body fluids or contaminated surfaces
After removing gloves
When moving from a contaminated-body site to a clean-body site during patient care
Summary of ‘No’ Responses
V.a.
All HCP are educated regarding appropriate indications for hand hygiene: Upon hire, prior to provision of care
All HCP are educated regarding appropriate indications for hand hygiene: Annually
HCP are required to demonstrate competency with hand hygiene following each training
Facility routinely audits (monitors and documents) adherence to hand hygiene.
Facility provides feedback from audits to personnel regarding their hand hygiene performance.
Hand hygiene policies promote preferential use of alcohol-based hand rub (ABHR) over soap and water in most clinical situations.
V.b.
Supplies necessary for adherence to hand hygiene (e.g., soap, water, paper towels, alcohol-based hand rub) are readily accessible to HCP in patient care areas.
Before contact with the patient
Before performing an aseptic task (e.g., insertion of IV or preparing an injection, administering eye drops)
After contact with the patient
After contact with objects in the immediate vicinity of the patient
After contact with blood, body fluids or contaminated surfaces
After removing gloves
When moving from a contaminated-body site to a clean-body site during patient care
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

VI. Personal Protective Equipment (PPE)
Incomplete Elements
VI.a.
HCP who use PPE receive training on proper selection and use of PPE: Upon hire, prior to provision of care
HCP who use PPE receive training on proper selection and use of PPE: Annually
HCP who use PPE receive training on proper selection and use of PPE: When new equipment or protocols are introduced
HCP are required to demonstrate competency with selection and use of PPE following each training.
Facility routinely audits (monitors and documents) adherence to proper PPE selection and use.
Facility provides feedback from audits to personnel regarding their performance with selection and use of PPE.
VI.b.
Sufficient and appropriate PPE is available and readily accessible to HCP.
PPE, other than respirator, is removed and discarded prior to leaving the patient’s room or care area. If a respirator is used, it is removed and discarded (or reprocessed if reusable) after leaving the patient room or care area and closing the door.
Hand hygiene is performed immediately after removal of PPE.
D. i. HCP wear gloves for potential contact with blood, body fluids, mucous membranes, non-intact skin, or contaminated equipment.
D. ii. HCP do not wear the same pair of gloves for the care of more than one patient.
D. ii. HCP do not wash gloves for the purpose of reuse.
E. i. HCP wear gowns to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated.
E. ii. HCP do not wear the same gown for the care of more than one patient.
Facial protection HCP wear mouth, nose, and eye protection during procedures that are likely to generate splashes or sprays of blood or other body fluids.
Summary of ‘No’ Responses
VI.a.
HCP who use PPE receive training on proper selection and use of PPE: Upon hire, prior to provision of care
HCP who use PPE receive training on proper selection and use of PPE: Annually
HCP who use PPE receive training on proper selection and use of PPE: When new equipment or protocols are introduced
HCP are required to demonstrate competency with selection and use of PPE following each training.
Facility routinely audits (monitors and documents) adherence to proper PPE selection and use.
Facility provides feedback from audits to personnel regarding their performance with selection and use of PPE.
VI.b.
Sufficient and appropriate PPE is available and readily accessible to HCP.
PPE, other than respirator, is removed and discarded prior to leaving the patient’s room or care area. If a respirator is used, it is removed and discarded (or reprocessed if reusable) after leaving the patient room or care area and closing the door.
Hand hygiene is performed immediately after removal of PPE.
D. i. HCP wear gloves for potential contact with blood, body fluids, mucous membranes, non-intact skin, or contaminated equipment.
D. ii. HCP do not wear the same pair of gloves for the care of more than one patient.
D. ii. HCP do not wash gloves for the purpose of reuse.
E. i. HCP wear gowns to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated.
E. ii. HCP do not wear the same gown for the care of more than one patient.
Facial protection HCP wear mouth, nose, and eye protection during procedures that are likely to generate splashes or sprays of blood or other body fluids.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

VII. Injection Safety
Incomplete Elements
VII.a.
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: Upon hire, prior to being allowed to prepare and/or administer parenteral medications
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: Annually
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: When new equipment or protocols are introduced
HCP are required to demonstrate competency with safe injection practices following each training.
Facility routinely audits (monitors and documents) adherence to safe injection practices.
Facility provides feedback from audits to personnel regarding their adherence to safe injection practices.
Facility has policies and procedures to track HCP access to controlled substances to prevent narcotics theft/diversion.
VII.b.
Injections are prepared using aseptic technique in a clean area free from contamination or contact with blood, body fluids or contaminated equipment.
Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and cartridge devices such as insulin pens).
The rubber septum on a medication vial is disinfected with alcohol prior to piercing.
Medication containers are entered with a new needle and a new syringe, even when obtaining additional doses for the same patient.
Single dose (single-use) medication vials, ampules, and bags or bottles of intravenous solution are used for only one patient.
Medication administration tubing and connectors are used for only one patient.
Multi-dose vials are dated by HCP when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle).
All sharps are disposed of in a puncture-resistant sharps container.
Filled sharps containers are disposed of in accordance with state regulated medical waste rules.
All controlled substances (e.g., Schedule II, III, IV, V drugs) are kept locked within a secure area.
HCP wear a facemask (e.g., surgical mask) when placing a catheter or injecting material into the epidural or subdural space (e.g., during myelogram, epidural or spinal anesthesia).
Summary of ‘No’ Responses
VII.a.
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: Upon hire, prior to being allowed to prepare and/or administer parenteral medications
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: Annually
HCP who prepare and/or administer parenteral medications receive training on safe injection practices: When new equipment or protocols are introduced
HCP are required to demonstrate competency with safe injection practices following each training.
Facility routinely audits (monitors and documents) adherence to safe injection practices.
Facility provides feedback from audits to personnel regarding their adherence to safe injection practices.
Facility has policies and procedures to track HCP access to controlled substances to prevent narcotics theft/diversion.
VII.b.
Injections are prepared using aseptic technique in a clean area free from contamination or contact with blood, body fluids or contaminated equipment.
Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and cartridge devices such as insulin pens).
The rubber septum on a medication vial is disinfected with alcohol prior to piercing.
Medication containers are entered with a new needle and a new syringe, even when obtaining additional doses for the same patient.
Single dose (single-use) medication vials, ampules, and bags or bottles of intravenous solution are used for only one patient.
Medication administration tubing and connectors are used for only one patient.
Multi-dose vials are dated by HCP when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle).
All sharps are disposed of in a puncture-resistant sharps container.
Filled sharps containers are disposed of in accordance with state regulated medical waste rules.
All controlled substances (e.g., Schedule II, III, IV, V drugs) are kept locked within a secure area.
HCP wear a facemask (e.g., surgical mask) when placing a catheter or injecting material into the epidural or subdural space (e.g., during myelogram, epidural or spinal anesthesia).
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

VIII. Respiratory Hygiene/Cough Etiquette
Incomplete Elements
VIII.a.
Facility has policies and procedures to contain respiratory secretions in persons who have signs and symptoms of a respiratory infection, beginning at point of entry to the facility and continuing through the duration of the visit. Policies include:
Offering facemasks to coughing patients and other symptomatic persons upon entry to the facility, at a minimum, during periods of increased respiratory infection activity in the community.
Providing space in waiting rooms and encouraging persons with symptoms of respiratory infections to sit as far away from others as possible.
Facility educates HCP on the importance of infection prevention measures to contain respiratory secretions to prevent the spread of respiratory pathogens.
VIII.b.
A. i. Posts signs at entrances with instructions to patients with symptoms of respiratory infection to: Inform HCP of symptoms of a respiratory infection when they first register for care, and Practice Respiratory Hygiene/Cough Etiquette (cover their mouths/noses when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after hands have been covered with respiratory secretions).
A. ii. Provides tissues and no-touch receptacles for disposal of tissues.
A. iii. Provides resources for performing hand hygiene in or near waiting areas.
Summary of ‘No’ Responses
VIII.a.
Facility has policies and procedures to contain respiratory secretions in persons who have signs and symptoms of a respiratory infection, beginning at point of entry to the facility and continuing through the duration of the visit. Policies include:
Offering facemasks to coughing patients and other symptomatic persons upon entry to the facility, at a minimum, during periods of increased respiratory infection activity in the community.
Providing space in waiting rooms and encouraging persons with symptoms of respiratory infections to sit as far away from others as possible.
Facility educates HCP on the importance of infection prevention measures to contain respiratory secretions to prevent the spread of respiratory pathogens.
VIII.b.
A. i. Posts signs at entrances with instructions to patients with symptoms of respiratory infection to: Inform HCP of symptoms of a respiratory infection when they first register for care, and Practice Respiratory Hygiene/Cough Etiquette (cover their mouths/noses when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after hands have been covered with respiratory secretions).
A. ii. Provides tissues and no-touch receptacles for disposal of tissues.
A. iii. Provides resources for performing hand hygiene in or near waiting areas.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

IX. Point-of-Care Testing
Incomplete Elements
IX.a.
HCP who perform point-of-care testing receive training on recommended practices: Upon hire, prior to being allowed to perform point-of-care testing
HCP who perform point-of-care testing receive training on recommended practices: Annually
HCP who perform point-of-care testing receive training on recommended practices: When new equipment or protocols are introduced
HCP are required to demonstrate competency with recommended practices for point-of-care testing following each training.
Facility routinely audits (monitors and documents) adherence to recommended practices during point-of-care testing.
Facility provides feedback from audits to personnel regarding their adherence to recommended practices.
IX.b.
New single-use, auto-disabling lancing device is used for each patient.
If used for more than one patient, the point-of-care blood testing meter is cleaned and disinfected after every use according to manufacturer’s instructions.
Summary of ‘No’ Responses
IX.a.
HCP who perform point-of-care testing receive training on recommended practices: Upon hire, prior to being allowed to perform point-of-care testing
HCP who perform point-of-care testing receive training on recommended practices: Annually
HCP who perform point-of-care testing receive training on recommended practices: When new equipment or protocols are introduced
HCP are required to demonstrate competency with recommended practices for point-of-care testing following each training.
Facility routinely audits (monitors and documents) adherence to recommended practices during point-of-care testing.
Facility provides feedback from audits to personnel regarding their adherence to recommended practices.
IX.b.
New single-use, auto-disabling lancing device is used for each patient.
If used for more than one patient, the point-of-care blood testing meter is cleaned and disinfected after every use according to manufacturer’s instructions.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

X. Environmental Cleaning
Incomplete Elements
X.a.
Facility has written policies and procedures for routine cleaning and disinfection of environmental surfaces, including identification of responsible personnel.
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures Upon hire, prior to being allowed to perform environmental cleaning
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures Annually
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures When new equipment or protocols are introduced
HCP are required to demonstrate competency with environmental cleaning procedures following each training.
Facility routinely audits (monitors and documents) adherence to cleaning and disinfection procedures, including using products in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).
Facility provides feedback from audits to personnel regarding their adherence to cleaning and disinfection procedures.
Facility has a policy/procedure for decontamination of spills of blood or other body fluids.
Operating rooms are terminally cleaned after last procedure of the day.
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to preoperative surgical scrub and hand hygiene
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Appropriate use of surgical attire and drapes
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to aseptic technique and sterile field
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Proper ventilation requirements in surgical suites
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Minimization of traffic in the operating room
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to cleaning and disinfection of environmental surfaces
Hospital provides feedback from audits to personnel regarding their adherence to surgical infection prevention practices.
X.b.
Supplies necessary for appropriate cleaning and disinfection procedures (e.g., EPA-registered disinfectants) are available.
High-touch surfaces in rooms where surgical or other invasive procedures (e.g., endoscopy, spinal injections) are performed are cleaned and then disinfected with an EPA-registered disinfectant after each procedure.
Cleaners and disinfectants are used in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).
HCP engaged in environmental cleaning wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection).
Summary of ‘No’ Responses
X.a.
Facility has written policies and procedures for routine cleaning and disinfection of environmental surfaces, including identification of responsible personnel.
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures Upon hire, prior to being allowed to perform environmental cleaning
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures Annually
Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures When new equipment or protocols are introduced
HCP are required to demonstrate competency with environmental cleaning procedures following each training.
Facility routinely audits (monitors and documents) adherence to cleaning and disinfection procedures, including using products in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).
Facility provides feedback from audits to personnel regarding their adherence to cleaning and disinfection procedures.
Facility has a policy/procedure for decontamination of spills of blood or other body fluids.
Operating rooms are terminally cleaned after last procedure of the day.
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to preoperative surgical scrub and hand hygiene
Hospital regularly audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Appropriate use of surgical attire and drapes
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to aseptic technique and sterile field
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Proper ventilation requirements in surgical suites
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Minimization of traffic in the operating room
Hospital routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including: Adherence to cleaning and disinfection of environmental surfaces
Hospital provides feedback from audits to personnel regarding their adherence to surgical infection prevention practices.
X.b.
Supplies necessary for appropriate cleaning and disinfection procedures (e.g., EPA-registered disinfectants) are available.
High-touch surfaces in rooms where surgical or other invasive procedures (e.g., endoscopy, spinal injections) are performed are cleaned and then disinfected with an EPA-registered disinfectant after each procedure.
Cleaners and disinfectants are used in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).
HCP engaged in environmental cleaning wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection).
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

XI. Device Reprocessing
Incomplete Elements
XI.a.
Facility has policies and procedures to ensure that reusable medical devices are cleaned and reprocessed appropriately prior to use on another patient.
The individual(s) in charge of infection prevention at the facility is consulted whenever new devices or products will be purchased or introduced to ensure implementation of appropriate reprocessing policies and procedures.
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: Upon hire, prior to being allowed to reprocess devices
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: Annually
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: When new devices are introduced or policies/procedures change.
HCP are required to demonstrate competency with reprocessing procedures (i.e., correct technique is observed by trainer) following each training.
Facility routinely audits (monitors and documents) adherence to reprocessing procedures.
Facility provides feedback from audits to personnel regarding their adherence to reprocessing procedures.
Facility has protocols to ensure that HCP can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in designated area).
Facility has policies and procedures outlining facility response (i.e., risk assessment and recall of device) in the event of a reprocessing error or failure.
Routine maintenance for reprocessing equipment (e.g., automated endoscope reprocessors, steam autoclave) is performed by qualified personnel in accordance with manufacturer instructions; confirm maintenance records are available.
XI.b.
Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the facility are available in the reprocessing area(s).
Reusable medical devices are cleaned, reprocessed (disinfection or sterilization) and maintained according to the manufacturer instructions.
Single-use devices are discarded after use and not used for more than one patient unless they have been appropriately reprocessed as described in the note below.
D. i. Adequate space is allotted for reprocessing activities.
D. ii. A workflow pattern is followed such that devices clearly flow from high contamination areas to clean/sterile areas (i.e., there is clear separation between soiled and clean workspaces).
Adequate time for reprocessing is allowed to ensure adherence to all steps recommended by the device manufacturer, including drying and proper storage.
HCP engaged in device reprocessing wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection).
Medical devices are stored in a manner to protect from damage and contamination.
Summary of ‘No’ Responses
XI.a.
Facility has policies and procedures to ensure that reusable medical devices are cleaned and reprocessed appropriately prior to use on another patient.
The individual(s) in charge of infection prevention at the facility is consulted whenever new devices or products will be purchased or introduced to ensure implementation of appropriate reprocessing policies and procedures.
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: Upon hire, prior to being allowed to reprocess devices
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: Annually
HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices: When new devices are introduced or policies/procedures change.
HCP are required to demonstrate competency with reprocessing procedures (i.e., correct technique is observed by trainer) following each training.
Facility routinely audits (monitors and documents) adherence to reprocessing procedures.
Facility provides feedback from audits to personnel regarding their adherence to reprocessing procedures.
Facility has protocols to ensure that HCP can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in designated area).
Facility has policies and procedures outlining facility response (i.e., risk assessment and recall of device) in the event of a reprocessing error or failure.
Routine maintenance for reprocessing equipment (e.g., automated endoscope reprocessors, steam autoclave) is performed by qualified personnel in accordance with manufacturer instructions; confirm maintenance records are available.
XI.b.
Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the facility are available in the reprocessing area(s).
Reusable medical devices are cleaned, reprocessed (disinfection or sterilization) and maintained according to the manufacturer instructions.
Single-use devices are discarded after use and not used for more than one patient unless they have been appropriately reprocessed as described in the note below.
D. i. Adequate space is allotted for reprocessing activities.
D. ii. A workflow pattern is followed such that devices clearly flow from high contamination areas to clean/sterile areas (i.e., there is clear separation between soiled and clean workspaces).
Adequate time for reprocessing is allowed to ensure adherence to all steps recommended by the device manufacturer, including drying and proper storage.
HCP engaged in device reprocessing wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection).
Medical devices are stored in a manner to protect from damage and contamination.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

XII. Sterilization of Reusable Devices
Incomplete Elements
Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to sterilization.
Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto devices.
Enzymatic cleaner or detergent is used for cleaning and discarded according to manufacturer’s instructions (typically after each use)
Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer’s instructions) after use.
After cleaning, instruments are appropriately wrapped/packaged for sterilization (e.g., package system selected is compatible with the sterilization process being performed, items are placed correctly into the basket, shelf or cart of the sterilizer so as not to impede the penetration of the sterilant, hinged instruments are open, instruments are disassembled if indicated by the manufacturer).
A chemical indicator (process indicator) is placed correctly in the instrument packs in every load.
A biological indicator, intended specifically for the type and cycle parameters of the sterilizer, is used at least weekly for each sterilizer and with every load containing implantable items.
For dynamic air removal-type sterilizers (e.g., prevacuum steam sterilizer), an air removal test (Bowie-Dick test) is performed in an empty dynamic-air removal sterilizer each day the sterilizer is used to verify efficacy of air removal.
Sterile packs are labeled with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date.
Sterilization logs are current and include results from each load.
Immediate-use steam sterilization, if performed, is only done in circumstances in which routine sterilization procedures cannot be performed.
Instruments that undergo immediate-use steam sterilization are used immediately and not stored.
After sterilization, medical devices are stored so that sterility is not compromised.
Sterile packages are inspected for integrity and compromised packages are reprocessed prior to use.
The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to the off-site facility.
Summary of ‘No’ Responses
Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to sterilization.
Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto devices.
Enzymatic cleaner or detergent is used for cleaning and discarded according to manufacturer’s instructions (typically after each use)
Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer’s instructions) after use.
After cleaning, instruments are appropriately wrapped/packaged for sterilization (e.g., package system selected is compatible with the sterilization process being performed, items are placed correctly into the basket, shelf or cart of the sterilizer so as not to impede the penetration of the sterilant, hinged instruments are open, instruments are disassembled if indicated by the manufacturer).
A chemical indicator (process indicator) is placed correctly in the instrument packs in every load.
A biological indicator, intended specifically for the type and cycle parameters of the sterilizer, is used at least weekly for each sterilizer and with every load containing implantable items.
For dynamic air removal-type sterilizers (e.g., prevacuum steam sterilizer), an air removal test (Bowie-Dick test) is performed in an empty dynamic-air removal sterilizer each day the sterilizer is used to verify efficacy of air removal.
Sterile packs are labeled with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date.
Sterilization logs are current and include results from each load.
Immediate-use steam sterilization, if performed, is only done in circumstances in which routine sterilization procedures cannot be performed.
Instruments that undergo immediate-use steam sterilization are used immediately and not stored.
After sterilization, medical devices are stored so that sterility is not compromised.
Sterile packages are inspected for integrity and compromised packages are reprocessed prior to use.
The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to the off-site facility.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

XIII. High-Level Disinfection of Reusable Devices
Incomplete Elements
Flexible endoscopes are inspected for damage and leak tested as part of each reprocessing cycle. Any device that fails the leak test is removed from clinical use and repaired.
Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to high-level disinfection.
Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto instruments.
Enzymatic cleaner or detergent is used and discarded according to manufacturer instructions (typically after each use).
Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer instructions) after use.
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Preparation
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Testing for appropriate concentration
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Replacement (i.e., upon expiration or loss of efficacy)
If automated reprocessing equipment (e.g., automated endoscope reprocessor) is used, proper connectors are used to assure that channels and lumens are appropriately disinfected.
Devices are disinfected for the appropriate length of time as specified by manufacturer instructions.
Devices are disinfected at the appropriate temperature as specified by manufacturer instructions.
After high-level disinfection, devices are appropriately rinsed as specified by the manufacturer.
Devices are dried thoroughly prior to reuse.
After high-level disinfection, devices are stored in a manner to protect from damage or contamination.
Facility maintains a log for each endoscopy procedure which includes: patient’s name and medical record number (if available), procedure, date, endoscopist, system used to reprocess the endoscope (if more than one system could be used in the reprocessing area), and serial number or other identifier of the endoscope used.
The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to off-site facility.
Summary of ‘No’ Responses
Flexible endoscopes are inspected for damage and leak tested as part of each reprocessing cycle. Any device that fails the leak test is removed from clinical use and repaired.
Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to high-level disinfection.
Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto instruments.
Enzymatic cleaner or detergent is used and discarded according to manufacturer instructions (typically after each use).
Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer instructions) after use.
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Preparation
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Testing for appropriate concentration
For chemicals used in high-level disinfection, manufacturer instructions are followed for: Replacement (i.e., upon expiration or loss of efficacy)
If automated reprocessing equipment (e.g., automated endoscope reprocessor) is used, proper connectors are used to assure that channels and lumens are appropriately disinfected.
Devices are disinfected for the appropriate length of time as specified by manufacturer instructions.
Devices are disinfected at the appropriate temperature as specified by manufacturer instructions.
After high-level disinfection, devices are appropriately rinsed as specified by the manufacturer.
Devices are dried thoroughly prior to reuse.
After high-level disinfection, devices are stored in a manner to protect from damage or contamination.
Facility maintains a log for each endoscopy procedure which includes: patient’s name and medical record number (if available), procedure, date, endoscopist, system used to reprocess the endoscope (if more than one system could be used in the reprocessing area), and serial number or other identifier of the endoscope used.
The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to off-site facility.
Action Items: ☐ Facility will conduct additional training for healthcare personnel (e.g., to correct a problem observed) ☐ Facility will improve regular training program, including incorporation of competency assessments ☐ Facility will initiate feedback program ☐ Facility will initiate auditing program ☐ Health dept. provided recommendation(s) at time of visit ☐ Facility will develop/update policies and procedures ☐ Health dept. provided resource(s)/tool(s) at time of visit ☐ Other (specify): Click here to enter text. Facility Response: ☐ Facility agrees with assessment in this domain ☐ Facility plans to take action to mitigate ☐ Other (specify): Click here to enter text.
All Items Confirmed
Notes/Recommendations: Click here to enter text.

Follow Up Activities:
☐ Repeat on-site assessment planned (date: Click here to enter a date.)
☐ Repeat remote (phone/email) assessment planned (date: Click here to enter a date.)
☐ Other (specify): Click here to enter text.

Other Comments:
Click here to enter text.

☐ IC Program and Infrastructure ☐ IC Training and Competency

☐ HCP Safety ☐ Surveillance/Reporting ☐ Hand Hygiene

☐ PPE ☐ Injection Safety ☐ Respiratory Hygiene ☐ POC Testing

☐ Environmental Cleaning ☐ Device Reprocessing

☐ Sterilization of Reusable Devices ☐ Disinfection of Reusable Devices